{"id":29845,"date":"2019-05-02T00:49:06","date_gmt":"2019-05-02T05:49:06","guid":{"rendered":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/?p=29845"},"modified":"2019-05-08T09:35:17","modified_gmt":"2019-05-08T14:35:17","slug":"lotus-tavr-fda-approval","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2019\/05\/02\/lotus-tavr-fda-approval\/","title":{"rendered":"Boston Scientific Gets FDA Approval For Lotus Edge TAVR!"},"content":{"rendered":"

The news coming out about transcatheter aortic valve replacement (TAVR)<\/a> devices is non-stop.<\/p>\n

First, we heard about the success of the low-risk TAVR clinical trials for PARTNER 3<\/a> and Evolut<\/a>.\u00a0 Now, I just learned that the Lotus Edge Transcatheter Aortic Valve System<\/a> just received a Food & Drug Administration approval following the REPRISE III research study.\u00a0 The Lotus is now indicated for severe aortic stenosis patients who are considered “high-risk” for surgical aortic valve replacement (SAVR).<\/p>\n

 <\/p>\n

\"\"<\/p>\n

 <\/p>\n


\nThis is a big deal for Boston Scientific, the manufacturer of Lotus, who is relatively unknown to the patients in the HeartValveSurgery.com community.\u00a0 However, Boston Scientific is a medical device juggernaut that had annual revenues of $9.8 billion in 2018.\u00a0 As you may know,\u00a0 Boston Scientific manufactures the Watchman device<\/a> for atrial fibrillation treatment and stroke prevention.<\/p>\n

You might be wondering, “We already have SAPIEN.\u00a0 We already have CoreValve.\u00a0 We already have Evolut. So, do we need another TAVR device?”<\/p>\n

It’s a great question.\u00a0 Honestly, I don’t have the answer.\u00a0 However, you must think there is something special about this new aortic valve replacement that would motivate Boston Scientific to invest the time and resources to commercialize this new TAVR.<\/p>\n

 <\/p>\n

What’s Unique About Lotus Edge TAVR?<\/h2>\n

According to Diagnostics & Interventional Cardiology<\/a>, “The Lotus is the only FDA-cleared aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also features a braided wire valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient’s native aortic valve.”<\/p>\n

As you might remember from our recent coverage of the low-risk TAVR clinical trials, paravalvular leak was sited as an opportunity for improved TAVR performance.<\/p>\n

Here’s a great video to help you learn more about the Lotus Edge:<\/p>\n

 <\/p>\n