CryoLife’s (Kennesaw, Georgia) decellularized replacement heart valve — used to replace diseased, damaged, malformed or malfunctioning pulmonary valves — has received FDA 510(k) clearance.

Children who face multiple surgeries for congenital heart defects will likely be the most significant beneficiaries of the new valves, according to the company, by potentially reducing the number of surgeries they must have over a lifetime.

“We believe the CryoValve SynerGraft [SG] pulmonary human heart valve is the first decellularized heart valve on the market,” D. Ashley Lee, CryoLife’s CFO/COO told Medical Device Daily. “We essentially remove the cells from the heart valve and you’re left with a collagen matrix.

“It’s a significant advancement for people with diseased pulmonic valves. Kids born with cardiac defects face a series of surgeries. The SG process will increase the durability of heart valves and reduce the number of those surgeries.”

The decellularized tissue potentially lowers the risk of an immune response and subsequent tissue rejection. The SG valves are also good choices for children because they avoid the need to take blood-thinning medications on a long-term basis and are less likely to calcify than heart valves from a pig or cow.

Lee said there may be other decellularized organs available by other tissue processing companies, but that this is the first heart valve.

The American Heart Association (Dallas) estimates that about 1 million Americans have a congenital heart defect. About 35,000 babies in the U.S. are born with a heart defect each year.

When human tissue is recovered from a cadaver for future implantation, it is typically inspected, cleaned and decontaminated to prevent infection, but the allograft remains otherwise unchanged. CryoLife’s SG technology removes allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. What remains is a scaffold of connective tissue that still functions like a human heart valve, according to the company.

“It takes much longer to process these heart valves,” Lee said. “We put them through a series of steps designed to remove the cellular debris, including [using] a series of solutions.”

He declined to further explain the process for proprietary reasons, but said the company didn’t have to alter its manufacturing or lab facilities to enable the new heart valve processing.

“We just had to alter the method,” he said, adding that CryoLife started processing the new heart valves on Friday.

The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects. In addition, it can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient’s defective aortic valve is removed and replaced with his own pulmonary valve.

The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.

The FDA issued its own statement about the clearance on Friday, an action generally reserved for products that it considers as significant advancements.

“Today’s clearance is a promising advance in allograft products,” said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health. “FDA welcomes innovations in manufacturing that provide more medical options for patients.”

At FDA’s request, CryoLife said it will do a post-clearance study to seek evidence for the potential and implied long-term benefits of the SynerGraft process. Data to be collected is expected to include long-term safety and hemodynamic function, immune response, and explant analysis. The data also is expected to reveal how many surgeries can be avoided in children with the new allograft compared to traditional methods.

Lee said data has been collected for about six years to date, and the longer-term information will be able to help CryoLife to ascertain whether or not the SynerGraft process actually reduces the immunogenicity of the transplanted heart valve and recellularizes with the recipients own cells.

CryoLife estimates the heart valves can be used in up to 5,000 surgeries annually in the U.S., and the company will likely be able to address the entire market, Lee said.

“We have capacity to do that right now, but it’s also determined by the number of hearts donated after a tragic event,” Lee said. “Currently get about 4,000 a year.”

The CryoValve SG may be available for shipment late in the first quarter of 2008.

Clearance of the SynerGraft valve was based on data comparing 342 SynerGraft valves, implanted between 2000 and 2004, to 1,246 traditional allograft heart valves sold by the company. The data included information on mortality, device-related re-operations, structural valve deterioration, endocarditis (an inflammation of the heart’s inner lining) and blood clots.

The FDA found that the SynerGraft valve performed at least as well as traditional allograft valves.

CryoLife is in a positive financial position, finishing 2007 with annual revenues of $94 million.

“We’re profitable and cash-flow positive,” Lee said.