FDA News

Lotus Edge becomes third TAVR system approved by FDA

Michael J. Reardon
Michael J. Reardon

Boston Scientific announced its mechanically expandable transcatheter aortic valve replacement system has been approved by the FDA for treatment of patients with severe aortic stenosis.

The device (Lotus Edge) is the third TAVR system approved in the United States, following a balloon-expandable system (Sapien family of products, Edwards Lifesciences) and a self-expanding system (CoreValve family of products, Medtronic).

Calcified annuli

“This device gives us an alternative for patients with extensive calcification of the aortic annulus,” Steven J. Yakubov, MD, FACC, FSCAI, John H. McConnell Chair of Advanced Structural Heart Disease, system chief of OhioHealth Structural Heart Disease and medical director of OhioHealth Research Institute at Riverside Methodist Hospital in Columbus, told Cardiology Today’s Intervention. “It also gives us the opportunity to have less chance of aortic insufficiency in these types of cases. This may allow us to perform TAVR more safely in calcified annuli.”

The system is approved for use in patients at high risk for surgery, according to a press release issued by the company.

Repositionable valve

According to the release, the system is the only one on the U.S. market that can be repositioned or completely recaptured once it is deployed.

“The Lotus is fundamentally different [than the other valves] in that it is a mechanically expanded valve so that we put it in position and we slowly expand it all the way to complete deployment,” Michael J. Reardon, MD, professor and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital, said in an interview. “It is never obstructed at any time and you don’t have to pace the heart. We can get it to complete lock implant and decide if we like it. If you do like it, you can let it go. If you don’t like it, you can move it. You always know what you’re going to get before you let it go, which is unique amongst the valves.”

The system also has a valve frame and seal designed to minimize paravalvular leak, the company stated in the release.

“[The sealing skirt] is an artificial material attached to the top and the bottom of the valve and halfway up,” Reardon told Cardiology Today’s Intervention. “As you shorten the valve, it actually pulls it together like pulling your sleeve up on your coat so that it crinkles out and moves out to fill out the slots.”

All of the components of this system may help improve patient outcomes, according to the press release.

“This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes,” Ian Meredith, AM, executive vice president and global chief medical officer for Boston Scientific, said in the release.

A controlled U.S. launch will begin in the coming weeks, according to the release. – by Darlene Dobkowski

For more information:

Michael J. Reardon, MD, can be reached at mreardon@houstonmethodist.org.

Steven J. Yakubov, MD, FACC, FSCAI, can be reached at steven.yakubov@gmail.com.

Disclosures: Meredith is an employee of Boston Scientific. Yakubov reports he is a steering committee member for the CoreValve trials sponsored by Medtronic and was an investigator in the Lotus clinical trial sponsored by Boston Scientific. Reardon reports he has received consultant fees paid to his institution from Boston Scientific.

Michael J. Reardon
Michael J. Reardon

Boston Scientific announced its mechanically expandable transcatheter aortic valve replacement system has been approved by the FDA for treatment of patients with severe aortic stenosis.

The device (Lotus Edge) is the third TAVR system approved in the United States, following a balloon-expandable system (Sapien family of products, Edwards Lifesciences) and a self-expanding system (CoreValve family of products, Medtronic).

Calcified annuli

“This device gives us an alternative for patients with extensive calcification of the aortic annulus,” Steven J. Yakubov, MD, FACC, FSCAI, John H. McConnell Chair of Advanced Structural Heart Disease, system chief of OhioHealth Structural Heart Disease and medical director of OhioHealth Research Institute at Riverside Methodist Hospital in Columbus, told Cardiology Today’s Intervention. “It also gives us the opportunity to have less chance of aortic insufficiency in these types of cases. This may allow us to perform TAVR more safely in calcified annuli.”

The system is approved for use in patients at high risk for surgery, according to a press release issued by the company.

Repositionable valve

According to the release, the system is the only one on the U.S. market that can be repositioned or completely recaptured once it is deployed.

“The Lotus is fundamentally different [than the other valves] in that it is a mechanically expanded valve so that we put it in position and we slowly expand it all the way to complete deployment,” Michael J. Reardon, MD, professor and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital, said in an interview. “It is never obstructed at any time and you don’t have to pace the heart. We can get it to complete lock implant and decide if we like it. If you do like it, you can let it go. If you don’t like it, you can move it. You always know what you’re going to get before you let it go, which is unique amongst the valves.”

The system also has a valve frame and seal designed to minimize paravalvular leak, the company stated in the release.

“[The sealing skirt] is an artificial material attached to the top and the bottom of the valve and halfway up,” Reardon told Cardiology Today’s Intervention. “As you shorten the valve, it actually pulls it together like pulling your sleeve up on your coat so that it crinkles out and moves out to fill out the slots.”

All of the components of this system may help improve patient outcomes, according to the press release.

“This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes,” Ian Meredith, AM, executive vice president and global chief medical officer for Boston Scientific, said in the release.

A controlled U.S. launch will begin in the coming weeks, according to the release. – by Darlene Dobkowski

For more information:

Michael J. Reardon, MD, can be reached at mreardon@houstonmethodist.org.

Steven J. Yakubov, MD, FACC, FSCAI, can be reached at steven.yakubov@gmail.com.

Disclosures: Meredith is an employee of Boston Scientific. Yakubov reports he is a steering committee member for the CoreValve trials sponsored by Medtronic and was an investigator in the Lotus clinical trial sponsored by Boston Scientific. Reardon reports he has received consultant fees paid to his institution from Boston Scientific.