This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Freedom SOLO Stentless Heart Valve
SOLO Smart Stentless Heart Valve
PMA Applicant: Sorin Group Canada Inc.
Address: Burnaby, British Columbia, Canada
Approval Date: June 24, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130011a.pdf
What is it? The Freedom SOLO Stentless Heart Valve is an artificial aortic valve that is intended 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 SOLO Stentless Heart Valve except that it contains a flexible holder that helps the surgeon sew the valve in place.
How does it work? The aortic valve opens so that blood can flow out. It then closes to keep blood from returning to the heart. 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.
When is it used? When the natural aortic heart valve does not open and close properly, it can lead to symptoms and life-threatening heart problems such as fainting, fatigue, chest pain, heart failure, or cardiac arrest. The doctor will listen to the patient’s heart or recommend an echocardiogram to see if it is functioning properly. An aortic heart valve can be malformed at birth, become damaged or diseased, or a previous artificial heart valve may begin to malfunction. Any of these conditions can result in blood flowing inefficiently through the heart, which may require a replacement of the aortic valve.
What will it accomplish? Once the aortic valve is replaced, symptoms should lessen or go away. The doctor will hear that the artificial valve is working better, or see that it is working better with an echocardiogram.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.