June 23, 2019

Medtronic and Edwards Issue Statements Supporting the CMS National Coverage Determination for TAVR

June 21, 2019—Medtronic plc and Edwards Lifesciences Corporation separately issued statements regarding the Centers for Medicare & Medicaid Services (CMS) final decision memo updating the transcatheter aortic valve replacement (TAVR) national coverage determination (NCD).

Medtronic stated that the CMS decision underscores the importance of high-quality evidence in shaping coverage policy and beneficiary access to life-saving therapies. Furthermore, the company commented,

“Medtronic supports the updated TAVR NCD and believes the new coverage policy allows for appropriate patient access to TAVR—especially for patients in rural communities—while still maintaining rigorous requirements for centers and operators providing the therapy. Medtronic has been an active participant over the past year during the National Coverage Analysis and its public commenting periods and provided several recommendations to support patients continuing to have sufficient access to TAVR therapy. We are pleased to see that today's decision is consistent with our position.”

In its press release, Edwards Lifesciences commented,

“We commend CMS on its thoughtful approach toward updating the TAVR policy. Throughout the NCD process, Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them. Often, the primary risk facing severe aortic stenosis patients is not treatment complications but the risk of not receiving treatment at all.”

Edwards' statement continued,

“Many of the core elements of the updated NCD better reflect today's practices in the treatment of patients with severe aortic stenosis, the needs of those patients, and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe aortic stenosis. We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the United States, which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development. We look forward to continuing to engage with all of the stakeholders around the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease.”


June 25, 2019

Mentice and Siemens Healthineers Collaborate on Simulation System in the Angiosuite

June 21, 2019

CDRH Provides Statement on Efforts to Increase Transparency in Medical Device Reporting