First U.S. Implant of New Stentless Valve from Sorin

Italian cardiovascular company Sorin Group has reported the first U.S. implant of its Solo Smart heart valve. The surgery was performed by David Heimansohn, M.D., at St. Vincent’s Heart Hospital, Indianapolis, Ind.

Solo Smart is the next generation of the Freedom Solo valve, which has been available in Europe since 2004. The company received U.S. Food and Drug Administration approval for the device in June.

According to the company, Solo Smart is the first and only valve with a removable stent to be approved in the United States.
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 differs from the company’s the Freedom Solo stentless heart valve in that it contains a flexible holder that helps the surgeon sew the valve in place.

The aortic valve opens so that blood can flow out. It then closes to keep blood from returning to the heart. The Solo Smart device 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.

“I am excited to have the Sorin Solo Smart stentless valve available to my patients,” said Heimansohn. “Solo Smart is a step forward in the treatment of aortic valve disease, as this surgical valve has superior hemodynamic performance, and is much easier to implant, requiring only a single suture line. It more resembles a native aortic valve in appearance and performance, offering the best hemodynamics during all conditions, and improving patients’ lives dramatically.”

“The first U.S. implant of Solo Smart is a huge milestone for Sorin,” said Michel Darnaud, president, Cardiac Surgery Business Unit, Sorin Group. “Solo Smart is the evidence of Sorin’s continuous commitment to providing new and innovative solutions to improve patients’ lives.”

The Sorin Group focuses on two major therapeutic areas: cardiac surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and cardiac rhythm management (pacemakers, defibrillators and noninvasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment).