Technology | October 23, 2014

FDA Clears Pair of Stentless Heart Valves from Sorin

Both models designed to replace a diseased, damaged or malfunctioning aortic heart valve

October 23, 2014 — The U.S. Food and Drug Administration (FDA) approved the Freedom Solo and Solo Smart stentless heart valves from Sorin Group Canada Inc. to replace a diseased, damaged or malfunctioning aortic heart valve.

The valve is made from natural tissue obtained from the sac that surrounds the heart of a cow. It is called stentless because the frame does not contain any metals or polymers. The Solo Smart stentless heart valve is identical to the Freedom stentless heart valve except that it contains a flexible holder that helps the surgeon sew the valve in place.

The Freedom Solo stentless heart valve replaces an aortic valve that does not properly close all the way so that blood leaks back into the heart, or does not open fully, so that blood flow through it is reduced. Either condition can result in serious health problems. The artificial valve is implanted by first placing the patient on a cardiopulmonary bypass machine, which takes over the task of breathing for the patient and pumping their blood throughout their body. Once on bypass, the surgeon then removes the existing aortic valve and sews the new one into place.

For more information:

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery| September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery| September 08, 2017
September 8, 2017 — ClearFlow Inc.
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices| September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial
News | Heart Valve Technology| September 05, 2017
Minneapolis Heart Institute Foundation announced it has enrolled the first-in-the-world patient in a clinical study to...
World's First Successful 52-mm Transcatheter Tricuspid Valve Implantation Completed in Italy
News | Heart Valve Technology| August 31, 2017
NaviGate Cardiac Structures Inc. (NCSI) announced that its Gate catheter-guided tricuspid atrioventricular valved stent...
Sponsored Content | Videos | Heart Valve Technology| August 30, 2017
Azeem Latib, M.D., MBBCh, FCP, interventional cardiologist at Columbus Hospital in Milan, Italy, discusses the latest
Overlay Init