Inspiris Heart Valve Mri Safety

[Janeen Bahrke]

TheINSPIRIS RESILIA valve delivers on the promise of better ongoing patient quality of life without the inconvenience of monitoring, dietary restrictions and reduction of participation in active lifestyles typically seen with a mechanical valve.1,2

The INSPIRIS RESILIA valve incorporates novel VFit technology, designed to enable valve-in-valve procedures in the future, at a time when patients are older and potentially at a higher risk for complications.

*Refer to device Instructions for Use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures. VFit technology is available on sizes 19 -25 mm.

WARNING: Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture. Refer to device instructions for use for full prescribing and safety information.

Complications and Side Effects: Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death.

SVD can be caused by a buildup of calcium that may impact long-term durability of bioprosthetic valves. Heart valves with RESILIA tissue are designed to address calcification challenges of conventional tissue valves, potentially allowing valves with RESILIA to last longer. The RESILIA tissue data from the COMMENCE aortic trial reported encouraging results with low rates of SVD (99.3% freedom from SVD), clinically stable gradients and freedom from reoperation (97.2%) through seven years.

"As bioprosthetic aortic valve replacement extends to younger and more active patients, valve durability is becoming increasingly important," said Thomas Beaver, M.D., Grant and Shirle Herron Chair, Professor and Chief of Cardiovascular Surgery, University of Florida College of Medicine. "The seven-year data from the COMMENCE aortic trial demonstrates strong clinical outcomes and excellent durability in a study of younger patients with a mean age of 65.1 years."

Current technologies utilizing this novel tissue include the INSPIRIS RESILIA aortic valve, the KONECT RESILIA aortic valved conduit, the MITRIS RESILIA mitral valve and the SAPIEN 3 Ultra RESILIA transcatheter aortic heart valve. In addition to its anti-calcification properties, RESILIA tissue also allows the valve to be stored under dry packaging conditions, facilitating ease of use in the operating room.

"Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease and our RESILIA tissue technology is designed for enhanced durability, supporting patients' improved quality of life," said Larry Wood, Edwards' corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. "The latest COMMENCE aortic trial data emphasizes the value of RESILIA tissue-based offerings in helping patients and their physicians with lifetime management of valve disease."

The COMMENCE aortic trial is a prospective, non-randomized, multicenter, single-arm investigational device exemption (IDE) trial comprised of 689 patients at 27 clinical sites across the United States and Europe. The trial is evaluating the safety and effectiveness of Edwards' bioprosthetic aortic valve with RESILIA tissue in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Long-term follow-up data were collected in a subset of these patients and will continue to be evaluated through 10 years.

LOS ANGELES, May 7, 2023 /PRNewswire/ -- Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE aortic trial, demonstrating low rates of structural valve deterioration (SVD) in bioprosthetic aortic valves with the company's innovative RESILIA tissue. The data, which represent the longest clinical follow-up for Edwards' bioprosthetic surgical aortic valve with RESILIA tissue with a mean follow-up of 7.7 years, were presented today at the 103rd annual meeting of the American Association for Thoracic Surgery.

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. 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. Investors are cautioned not to unduly rely on such forward-looking statements.

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 as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, and the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS RESILIA, SAPIEN and RESILIA are trademarks and service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Indications: The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

Contraindications: The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections, or who have significant annuloplasty ring dehiscence.

Potential Adverse Events: Potential risks associated with the overall procedure, including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, atrium, septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; thoracic bleeding; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury or brachial plexus injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes (e.g., wound infection, hematoma, and other wound care complications) at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; left ventricular outflow tract obstruction; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.

3a8082e126