Tag: Cardiac Surgery

Abbott’s Latest Heart Pump FDA Approved

Abbott received FDA approval for its HeartMate 3 left ventricular assist device (LVAD), a pump designed to augment cardiac output in patients with severe heart failure that are waiting for their heart to recover or that are in line for a transplant. Featuring the “Full MagLev”, as the technology is called by Abbott, the HeartMate [&hell (Read more...)

Injectable Tissue Patch to Fix Broken Hearts

Scientists at the University of Toronto have developed a bandage-like patch that can be delivered into the heart through a needle, in combination with stem cells allowing for minimally invasive cardiac tissue repair, currently an impossible task. After a massive heart attack, myocardial tissue damage can significantly reduce the cardiac output. One (Read more...)

Medtronic CoreValve Evolut PRO TAVR Valve Cleared in Europe

Medtronic won the European CE Mark and is introducing its CoreValve Evolut PRO transcatheter aortic valve in Europe for patients with severe aortic stenosis who are considered at intermediate, high, or extreme risk of not doing well from an open heart surgery. The Evolut PRO features an external porcine pericardial tissue wrap that helps (Read more...)

Medtronic’s CoreValve Evolut Transcatheter Aortic Valves Now Approved for Intermediate Risk Patients

Medtronic has announced that its CoreValve Evolut transcatheter aortic valve replacement platform, consisting of CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is now FDA approved for patients with “symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.” Previously, the products were o (Read more...)

Edwards INSPIRIS RESILIA Aortic Valve Now Approved in U.S.A.

Edwards Lifesciences has announced that the FDA has issued approval for its INSPIRIS RESILIA prosthetic aortic valve, which is based on the popular Carpentier-Edwards PERIMOUNT device. Cleared in Europe just under a year ago, the INSPIRIS RESILIA features flaps made from RESILIA material, a tissue developed by Edwards that helps maintain the i (Read more...)

Edwards SAPIEN 3 Cardiac Valve FDA Approved for Mitral and Aortic Valve-in-Valve Procedures

Edwards Lifesciences received FDA approval for its SAPIEN 3 transcatheter prosthetic heart valve to be used for valve-in-valve procedures. Indicated for placement within both the aortic and mitral valves in patients at risk of undergoing open heart surgery to remove an existing valve, the SAPIEN 3 can reside within a previously implanted biopr (Read more...)

Sentinel Cerebral Protection System for Preventing Strokes During Transcatheter Valve Repairs Cleared by FDA

While transcatheter aortic valve repair (TAVR) procedures can help avoid open heart surgeries in many fragile patients, there is a substantial risk that embolic debris is released from the calcified valves. The brain is particularly in danger, as the dislodged material can block blood vessels feeding it and result in strokes. Claret Medic (Read more...)