Edwards Lifesciences files official comment on CMS' proposed TAVR National Coverage Determination

Monday 5th March, 2012

 

IRVINE, CA, March 05, 2012 -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, reported that on March 3, 2012, the company filed its official response to the Centers for Medicare & Medicaid Services (CMS) on its Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

The company commended CMS for proposing flexible coverage for TAVR for all indications approved by the U.S. Food and Drug Administration (FDA), providing reimbursement for both current and future TAVR device approvals. Edwards said in its comment that it believes "such a policy benefits Medicare patients in need of treatment by providing uniform and timely access to new TAVR indications upon FDA approval." Edwards applauded CMS for recognizing the importance of the multi-disciplinary heart team in the treatment of TAVR patients, and supported CMS' proposal to require that all TAVR patients be enrolled in a qualified prospective registry that tracks patient outcomes. In filing its comment, the company noted the significant contributions made by the professional medical societies to the development of this draft policy.

The company also addressed in its response the areas of the proposed NCD that it believes would benefit from more careful consideration of patient impact. Edwards stated that the CMS proposal to limit coverage of clinical trials to "superiority trials" undermines efforts to promote continued U.S.-based clinical research for Medicare patients. There are also important, yet relatively small, patient populations that would be well served by further studies -- and that may not get treatment if the proposed conditions are not revised. In addition, the company believes that for this team-centric procedure, the credentialing of facilities and heart teams is far more relevant than traditional physician-based credentialing. Edwards proposed alternative criteria for both qualifying the establishment of a TAVR center and, once established, additional criteria for maintaining and improving outcomes.

Edwards' comment also reviewed the substantial body of evidence from The PARTNER Trial demonstrating that TAVR benefits patients with severe aortic stenosis. The PARTNER Trial showed that TAVR with the Edwards SAPIEN valve decreased all-cause mortality by 20 percentage points in inoperable patients at one year compared to the current standard of care. Inoperable TAVR patients in the trial also reported an improvement in their quality of life -- with researchers reporting that at one year, patients experienced significant cardiovascular and physical health benefits. For high-risk operable patients in The PARTNER Trial, TAVR also has been shown on average to enable faster procedural times, shorter post-operative hospital stays and shorter recovery periods. Published studies established that TAVR is a cost-effective therapy compared to commonly utilized therapies for other highly comorbid conditions.

CMS is expected to issue its final NCD within approximately 60 days.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com (You will be visiting a website outside of PCRonline, we are not responsible for its contents).

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 regarding potential outcomes, benefits and risks of a National Coverage Determination for transcatheter valve replacement. 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 the outcomes 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 regulatory decisions, expanded clinical experience, and market developments. 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, 2011.
SOURCE: Edwards