Edwards SAPIEN 3 Valve Receives FDA Approval For Aortic, Mitral Valve-In-Valve Procedures

IRVINE, Calif., June 5, 2017 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter heart valve. The SAPIEN 3 valve is the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.

“Expansion of the SAPIEN 3 device indication to include valve-in-valve procedures is a meaningful advancement for
patients at high risk of an additional open-heart valve procedure, particularly for those in need of a safe alternative for mitral valve replacement,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves.

This anticipated FDA approval of the indication expansion was supported by real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The TVT Registry includes information and outcomes on patients undergoing transcatheter valve replacement and repair procedures in the United States.

“This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery,” said John Carroll, M.D., professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver and member of the TVT Registry Steering Committee. “I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its ability to play an important role in assessing ‘real-world’ clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve.”

The Edwards SAPIEN 3 valve was approved by the FDA in 2015 for severe, symptomatic aortic stenosis patients at high risk for open-heart surgery, and, in 2016, received approval for the treatment of patients who are at intermediate risk for open-heart surgery. The SAPIEN 3 valve builds on Edwards’ decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.

About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.  Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.comand follow us on Twitter @EdwardsLifesci.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements made by Mr. Wood and Dr. Carroll.  Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated outcomes of longer term clinical experience with the product, or unanticipated quality, manufacturing or regulatory issues. These factors are detailed in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

 

SOURCE Edwards Lifesciences Corporation
ARTICLE SOURCE PR Newswire

How Surgical And Patient Monitoring Products Are Driving Medtronic’s Growth

The Surgical and Patient Monitoring business has been a cornerstone of Medtronic‘s growth. The company has grown both organically and inorganically in this market. We estimate that this business constitutes nearly 40% of Medtronic’s value, with nearly $11.5 billion in annual revenue and close to $8 billion in annual gross profit. It is comprised of 3 key segments – Surgical Solutions, Patient Monitoring and Recovery Products, and Surgical Technologies. Medtronic has benefited from the adoption of minimally invasive surgery, expansion in emerging markets such as China, India and Brazil, and acquisitions that have improved the company’s competitive position. Below we take a brief look at how the Surgical and Patient Monitoring business is driving Medtronic’s growth.

Our price estimate of $103 for Medtronic is nearly 20% above the market.

Surgical Solutions – Nearly $5.5 Billion In Annual Revenue

The Surgical Solutions segment includes products in the fields of minimally invasive gastrointestinal diagnostics, ablation, and interventional lung solutions. Surgical Solutions saw strong growth in the recently concluded quarter, driven by the adoption of new products such as endo stapling specialty reloads, the Valleylab FT10 energy platform, and LigaSure vessel sealing instruments. With improved safety, decreased scarring and decreased length of hospital stays, minimally invasive surgery procedures have grown over the years. This trend is likely to continue, and with the Covidien acquisition, Medtronic has gained a strong foothold in the market.

Patient Monitoring And Recovery – Nearly $4.4 Billion In Revenue

Medtronic’s Patient Monitoring and Recovery business develops, manufactures and markets products and therapies to enable complication-free recovery and enhance patient outcomes. The segment grew 4% in the last quarter, driven by re-commercialization of the Puritan Bennet 980 ventilator, and growth in capnography disposables and Nellcor pulse oximetry products. We expect this growth to continue. As many as 10% of adults aged 40 and older globally are believed to suffer from moderate or severe COPD (Chronic Obstructive Pulmonary Disease). This is expected to increase the demand for respiratory ventilators. Additionally, the growth in the number of critical emergency admissions will fuel the demand for respiratory ventilators in rapid response vehicles.

Surgical Technologies – Nearly $1.6 Billion In Annual Revenue

This segment includes devices and therapies for treating ear, nose, & throat and neurological problems along with image-guided surgery and intra-operative imaging systems that enhance surgical planning during certain surgeries. In the last few years, several acquisitions, such as those of Salient Surgical Technologies and PEAK Surgical in 2011, have helped increase Medtronic’s competitiveness in the market. The sales of StealthStation S7, which offers personalized navigation support to surgical staff, and O-Arm Imaging Systems, which offers multi-dimensional surgical imaging, have been growing. Medtronic’s nerve monitoring system has also seen encouraging adoption among surgeons as it helps them keep a check on major motor nerves during ENT surgeries, and has been useful in other procedures performed by endocrine, general, and peripheral surgeons.

Article from: Forbes

Medtronic RESOLUTE ONYX(TM) 2.0 mm Clinical Study Meets Primary Endpoint in Extra-Small Vessels at One-Year

First-Ever Study on 2.0 mm DES, EuroPCR Late-Breaking Data Show Exceptional Deliverability and No Stent Thrombosis for the Resolute Onyx DES

DUBLIN and PARIS- May 18, 2017 – Medtronic plc (NYSE: MDT) today announced that the Resolute Onyx(TM) Drug-Eluting Stent (DES) met its primary endpoint of Target Lesion Failure (TLF) at one year for the treatment of coronary artery disease in extra-small vessels. Results from the RESOLUTE ONYX 2.0 mm Clinical Study were presented today as a Hot Line/Late-Breaking Trial Session at the 2017 EuroPCR Annual Meeting and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.

It is estimated that approximately 65 percent of extra-small vessels are located in critical locations of the heart, making them significant lesions to treat.1 Designed specifically for extra-small vessels, Resolute Onyx 2.0 mm DES yielded excellent clinical outcomes in the study compared to a pre-specified performance goal with patients experiencing significantly low rates of TLF at one year (5.0 percent, p<=0.001). The study enrolled 101 patients with extra-small vessel sizes (2.0 mm – 2.25 mm) who received the Resolute Onyx 2.0 mm diameter DES across 20 sites in the United States and Japan.

“Treating coronary disease in extremely small arteries presents a real clinical challenge, as these lesions tend to be located in difficult-to-reach areas of the heart, have greater restenosis rates, and until now, we lacked the right stents to treat them safely and successfully,” said Matthew J. Price, M.D., interventional cardiologist at Scripps Clinic in La Jolla, Calif. and principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study who presented the one-year data at EuroPCR. “The excellent clinical performance we observed demonstrates the importance of designing stents like the Resolute Onyx DES that address a relevant unmet need. Thinner struts with enhanced radiopacity and a lower crossing profile provide excellent deliverability, and the stent can be over-expanded to treat tapered, challenging lesions.”

In the study, the events included in the TLF primary endpoint were low at one-year, as defined by low target-vessel MI (3 percent), low target lesion revascularization (2 percent) and no cardiac death. Additionally, Resolute Onyx DES showed no stent thrombosis.

The Resolute Onyx DES is the first and only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables greater deliverability and conformability to the vessel wall. With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core Wire Technology also enables thinner struts while maintaining structural strength.

“The RESOLUTE ONYX 2.0 mm Clinical Study builds on the positive body of evidence supporting the clinical performance of the Resolute Onyx stent,” said Jason Weidman, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. “These initial results reinforce the unique design of the Resolute Onyx, providing physicians and patients around the globe with the gold standard in drug-eluting stents.”

The Resolute Onyx 2.0 mm diameter DES are for investigational use only in the United States. The Resolute Onyx DES received approval by the Food and Drug Administration (FDA) in April 2017 and is now available for use in the United States for a broad range of sizes from 2.25 mm – 5.0 mm. It is also approved for use in Europe and other countries that recognize the CE (Conformité Européene) Mark.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Schunkert et al. JACC July 1999

Contacts:
Joey Lomicky Public Relations +1-763-526-2494

Ryan Weispfenning Investor Relations +1-763-505-4626

Image belongs to Medtronic.

SOURCE Medtronic

Cook Medical’s magnetic esophageal repair device for infants earns FDA nod

The FDA has authorized the use of Cook Medical’s device for the treatment of infants born with a defect that causes a gap in the esophagus. It was OK’d via the agency’s Humanitarian Device Exemption pathway.

The Flourish device is designed to treat esophageal atresia in infants up to one year old. The congenital defect, where the esophagus grows in two separate segments, makes it impossible for babies to feed normally. It is lethal unless it is treated, according to Boston Children’s Hospital. It is usually treated by surgically connecting the two ends of the esophagus. They are fed intravenously until the gap can be repaired.

Babies with the condition may also have a tracheoesophageal fistula, which can cause fluids from the esophagus to enter the airways and cause breathing problems.

“This new device provides a nonsurgical option for doctors to treat esophageal atresia in babies born with this condition,” said William Maisel, M.D., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a statement. But it should only be used for infants who don’t have a tracheoesophageal fistula or have had the fistula surgically fixed.

The device works by magnetically pulling the two ends of the esophagus together, according to the statement. A physician inserts one catheter through the infant’s mouth and the other through the stomach. The magnetic ends of the catheter attract each other and this motion brings the two ends of the esophagus together over several days. The infant may be fed normally once the catheters are removed.

The device is not indicated for infants whose esophagus segments are more than 4 centimeters apart, according to the statement. Safety data from 16 patients showed that all 16 infants had their esophagus connect within three to 10 days after treatment. But 13 of them developed narrowing in their esophagus—which may also occur from traditional surgical repair—that needed another procedure.

SOURCE http://www.fiercebiotech.com/medical-devices/cook-medical-s-magnetic-esophageal-repair-device-for-infants-earns-fda-nod

The Boston Scientific LOTUS™ Valve System Demonstrated Superior Efficacy to CoreValve® in Global REPRISE III Trial at One Year

PARIS and MARLBOROUGH, Mass., May 16, 2017 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced positive results from the REPRISE III clinical trial, presented at the annual EuroPCR Scientific Program, in Paris.  Data from the study demonstrated that the LOTUS Valve System*, a transcatheter aortic valve implantation (TAVI) system, showed superiority over the CoreValve® TAVI System platform** for the primary effectiveness endpoint and non-inferiority for the primary safety endpoint.

The primary effectiveness endpoint, a composite of all death, disabling stroke and moderate or greater paravalvular aortic leakage (PVL) at one year, was lower with the LOTUS Valve system compared to the CoreValve platform (16.7% vs. 29.0%, p<0.001). The LOTUS Valve system also demonstrated non-inferiority to CoreValve platform for the primary safety endpoint which was a composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage two or three acute kidney injury or major vascular complications through 30 days.

The pre-specified secondary endpoint demonstrated the LOTUS Valve system had significantly lower rates of moderate to severe PVL occurrences when compared to the CoreValve platform (2.0% vs. 11.1%, p<0.001).

“The excellent results seen in this large randomized trial, particularly the superior performance in efficacy and the continued demonstration of low PVL rates, further establish the advantages of the LOTUS Valve system,” said Ted E. Feldman, M.D., director, Cardiac Catheterization Laboratory, NorthShore University HealthSystem in Evanston, Illinois, and co-investigator of the REPRISE III trial. “With the LOTUS Valve system, I have confidence that I can position the valve accurately in every case and achieve good outcomes for my patients.”

REPRISE III is the first head-to-head pivotal study comparing two different TAVI platforms: the LOTUS Valve system and the CoreValve platform, including both CoreValve and EvolutR.  It is a multi-center, randomized controlled trial that included 912 patients from the United States, Europe, Canada and Australia with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement.

“We are very excited by the performance of the LOTUS Valve system in this trial as it represents a crucial piece of clinical evidence for the LOTUS platform,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific. “We believe that these data, along with upcoming findings to be shared from the RESPOND and RESPOND Extension studies, can further illustrate the unique clinical benefits that this system offers physicians for the treatment of patients.”

*The LOTUS Valve System is not available for sale.
** CoreValve and EvolutR are registered trademarks of Medtronic.

About Aortic Valve Disease
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart.  Aortic valve stenosis is the process of thickening and stiffening of the valve, resulting in restricted valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately three percent of the population over age 65 and five percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the closing and integration of acquisitions; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS

U.S. Media: Trish Backes
(651) 582-5887 (office)
Trish.Backes@bsci.com

European Media: Chiara Ennas
44 1442 411618 (office)
Chiara.Ennas@bsci.com

Investor Relations: Susie Lisa, CFA
(508) 683-5565 (office)
investor_relations@bsci.com

 

SOURCE http://www.prnewswire.com/news-releases/the-boston-scientific-lotus-valve-system-demonstrated-superior-efficacy-to-corevalve-in-global-reprise-iii-trial-at-one-year-300458303.html

Related Links

http://www.bostonscientific.com

Boston Scientific Announces Positive European Registry Results For WATCHMAN™ Left Atrial Appendage Closure Device

Largest Prospective Study of the WATCHMAN Device Presented as Late-Breaking Trial at Heart Rhythm 2017

MARLBOROUGH, Mass., May 12, 2017 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced positive safety and efficacy rates of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry presented during a late-breaking clinical trial session at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions in Chicago. Data confirmed that the WATCHMAN device had a high implant success rate and was effective in stroke reduction for patients with non-valvular atrial fibrillation (AF), including those patients deemed unsuitable for oral anticoagulation.

The prospective, single-arm, multicenter EWOLUTION registry evaluated 1,025 patients with non-valvular AF who have a high risk for stroke and systemic embolism.  At one year post implantation of the device, the results demonstrated an 84 percent reduction in the annual stroke rate (1.1 vs 7.2/100 pt-years)  as compared to predicted rates of untreated patients with similar risk profile and a reduction of 48 percent in the annual rate of major bleeding (2.6 vs 5.0/100 pt-years) as compared to predicted rates for patients treated with warfarin.*

“This impressively low ischemic stroke rate favors left atrial appendage closure as an important therapy for patients ineligible for long-term oral anticoagulation,” said Lucas V.A. Boersma, M.D., Ph.D., study principal investigator and electrophysiologist at St. Antonius Hospital, the Netherlands. “The results further validate the utility of the WATCHMAN device as an excellent alternative to anticoagulant therapy and its related bleeding risks for patients with non-valvular AF.”

In the study, patients were enrolled at 47 centers throughout Europe, Russia and the Middle East. More than 70 percent of the patients were deemed unsuitable for short or long-term anticoagulation at the time of WATCHMAN implantation. Transient ischemic attacks, ischemic stroke, vascular disease and a history of major bleeding were present in approximately half of the patients.

“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific.

Additional EWOLUTION data will be presented on May 18 at the annual EuroPCR Scientific Congress in Paris.

The WATCHMAN device was CE-marked in 2005 to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular AF who are eligible for anticoagulation therapy, and in 2012 the CE Mark indication was expanded to include those who have a contraindication to anticoagulation therapy. In 2015, the device received FDA approval for patients with non-valvular AF who are at high stroke risk, suitable for warfarin and are seeking an alternative to long-term warfarin therapy. The Centers for Medicare and Medicaid Services (CMS) began covering percutaneous LAAC therapy for Medicare beneficiaries in February 2016 when patients meet the specific criteria outlined in the agency’s final National Coverage Determination (NCD).

For more information on the WATCHMAN device, visit www.watchman.com.

*CHA2DS2 VASc and HAS-BLED scores have been validated to predict annual rates of ischemic stroke and bleeding, respectively. In order to provide context for the results given the abse
nce of a control group, analyses were performed to compare EWOLUTION event rates to these historical rates for patients of a similar risk profile.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and product performance and impact.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS:
Trish Backes
Media Relations
(651) 582-5887 (office)
Trish.Backes@bsci.com

Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com

Image is property of Boston Scientific.

SOURCE http://www.prnewswire.com/news-releases/boston-scientific-announces-positive-european-registry-results-for-watchman-left-atrial-appendage-closure-device-300456874.html

Related Links

http://www.bostonscientific.com

Edwards’ Novel Self-Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient Outcomes

PARIS, May 17, 2017 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced late-breaking data at EuroPCR 2017 demonstrating excellent clinical outcomes for transcatheter aortic valve replacement (TAVR) patients treated with the Edwards CENTERA valve. These new 30-day results are the first data presented on the self-expanding Edwards CENTERA valve.

For severe, symptomatic aortic stenosis patients at high risk of open-heart surgery, the Edwards CENTERA valve demonstrated a very high survival rate of 99 percent, a low 2.5 percent disabling stroke rate and a 4.9 percent permanent pacemaker rate – the lowest rate ever reported in a multi-center trial for a self-expanding valve. Additionally, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and no severe paravalvular leak. All 203 patients in the study were treated via the transfemoral access route with the majority (174 patients) under conscious sedation.

The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile 14-French delivery system that features a motorized handle that results in stable valve deployment. The valve is uniquely packaged – fully pre-attached which facilitates simple and rapid device preparation.

“The Edwards CENTERA valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk TAVR population,” said Didier Tchétché, M.D., of Clinique Pasteur in Toulouse, France, who presented the data. “In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians.”

CENTERA-EU Trial patients were enrolled in 23 centers in Europe, Australia and New Zealand and will be followed for five years. The Edwards CENTERA valve is an investigational device not yet available commercially in any country. Edwards anticipates it will receive CE Mark approval for the CENTERA valve during the fourth quarter.

Dr. Tchétché is a consultant to Edwards Lifesciences.

About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Dr. Tchétché’s statements and statements regarding expected future product benefits and results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected outcomes after longer term clinical experience with the product; or unanticipated quality, manufacturing or regulatory delays or issues. These factors are detailed in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, and CENTERA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE http://www.prnewswire.com/news-releases/edwards-novel-self-expanding-transcatheter-heart-valve-demonstrates-excellent-early-patient-outcomes-300459074.html

LATE-BREAKING DATA ON ABBOTT’S MITRACLIP® SYSTEM SHOW CONTINUED BENEFIT FOR PEOPLE WITH MITRAL REGURGITATION, MOST COMMON HEART VALVE DISEASE

– 92.8% procedural success observed in reducing leaky heart valve
– 80.0% of those treated free from repeat heart failure re-hospitalization
– 85.9% of patients were discharged to home after two-day average hospital stay

WASHINGTON, March 18, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced favorable one-year outcomes from the largest study of real-world experience for the MitraClip system in transcatheter mitral valve repair (TMVR) procedures in the United States. MitraClip treats people with degenerative mitral regurgitation (DMR, also known as leaky heart valve), a serious condition involving a dysfunction of the heart’s mitral valve, which regulates blood flow into the heart’s main pumping chamber.

The study analyzed data from the Transcatheter Valve Therapy (TVT) registry involving nearly 3,000 DMR patients who were high-risk for surgery. Following minimally invasive implantation with MitraClip, patients had significant improvements, including 92.8 percent of patients achieving post-procedural mitral regurgitation (MR) severity grade of less than or equal to 2 (acute procedural success defined as MR ≤2). In addition, 80.0 percent of MitraClip patients remained free from heart failure (HF) re-hospitalization in the year after implantation. Most patients—85.9 percent of people treated—were discharged to their homes after an average hospital stay of only two days. The average age of patients was 82.

The data were presented by Paul Sorajja, M.D., director of the Center of Valve and Structural Heart Disease at Minneapolis Heart Institute, cardiologist at Abbott Northwestern Hospital in Minneapolis and principal investigator of the study, during a late-breaking featured clinical research session of the American College of Cardiology’s (ACC) 66th Annual Scientific Session.

“The consistent one-year results seen in this study validate that treatment with MitraClip can provide meaningful reduction in the severity of mitral regurgitation,” said Dr. Sorajja. “The consistency of data over time in this large patient registry underscore the valuable impact MitraClip has on the overall health of very sick people living with this silent killer.”

Mitral regurgitation is a debilitating, progressive and life-threatening disease in which the leaflets of the mitral valve do not close completely, causing blood to flow backward and leak into the left atrium of the heart during the cardiac cycle. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly.

Nearly one in ten people over the age of 75 have moderate to severe MR1 , which is frequently difficult to diagnose. Patients often may not be eligible for the standard-of-care surgery because of advanced age, frailty, multiple comorbidities or other complicating factors. Until the regulatory approval of MitraClip, these high surgical risk patients could only manage their symptoms, such as shortness of breath and fatigue, with medications that did not stop the progression of the disease.

“Abbott’s goal is to improve health, and our MitraClip therapy provides a much-needed solution for gravely ill people who have very few options,” said Michael Dale, general manager of Abbott’s structural heart business. “The consistency in data across multiple trials reinforce the nearly immediate impact that MitraClip has on people’s quality of life, allowing them to lead fuller, longer lives.”

About the Transcatheter Valve Therapy (TVT) Registry
The STS/ACC TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures and emerging treatments for valve disease patients. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology, the TVT Registry is designed to monitor the safety and efficacy of these new technologies for the treatment of valve disease. Through the capture and reporting of patient demographics, procedure details, and facility and physician information, the TVT Registry provides a data repository capable of delivering insight into clinical practice patterns and patient outcomes.

About MitraClip
The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR > 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. The MitraClip System is available in the United States and in more than 50 countries around the world. More information, including important safety information, can be found at http://www.abbottvascular.com/docs/ifu/structural_heart/eIFU_MitraClip.pdf

About Abbott
At Abbott, we’re committed to helping you live your best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. https://www.ncbi.nlm.nih.gov/pubmed/16980116

SOURCE: http://abbott.mediaroom.com/2017-03-18-Late-Breaking-Data-on-Abbotts-MitraClip-R-System-Show-Continued-Benefit-for-People-with-Mitral-Regurgitation-Most-Common-Heart-Valve-Disease