Children born with congenital heart defects often face numerous open-heart surgeries because valves fail after just a few years. Repeatedly opening a child's chest to implant a new valve presents even more complications the next time.

Edwards Lifesciences (Irvine, California) has initiated a feasibility study of a procedure that will enable physicians to percutaneously implant the company's Sapien transcatheter heart valve, rather than opening the chest.

"These patients are born with congenital heart defects," Larry Wood, Edwards' corporate VP, transcatheter valve replacement, told Medical Device Daily. "Some of them have a procedure where they take the native pulmonary valve and switch to aortic. Or they have surgery to replace their valve with a cryopreserved human valve. They may have this surgery as an infant."

But, he added, "Tissue valves wear out, so they need repeated surgeries. We're trying to take one or two surgeries out their treatment course. If you can get patients to avoid a surgery or two, you give them five to 10 years for technology to develop and then adult treatment options become available."

The current study addresses a congenital condition in which the valve between the right ventricle and the pulmonary artery is nonfunctional.

Physicians have successfully implanted the Sapien valve percutaneously in the first three patients of a 30-patient trial at Rush Center for Congenital and Structural Heart Disease (Chicago).

The surgery was performed by entering through an incision in the groin and threaded up through the femoral artery. The Sapien, a bovine pericardial valve, is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve.

Wood said all three patients are "recovering nicely."

The FDA conditionally approved this investigational device exemption clinical trial in late 2007. The study will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application. Wood said a subsequent, larger trial would likely be necessary for final FDA approval.

The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.

Edwards' physician partners performed the first U.S. transcatheter pulmonic case on a compassionate basis in December 2005. That compassionate case has been successful.

Wood said there are between 2,000 and 4,000 children in the U.S. who present with these birth defects. "For these patients, there are no devices to treat this condition. This will allow us to address an unmet clinical need. It's not a huge lucrative [market] opportunity, but we can help these kids who are not really well served now," he said.

The Sapien heart valve also is being studied in the Placement of AoRTic traNscathetER valves (PARTNER) U.S. pivotal trial for the treatment of patients with severe aortic heart valve stenosis (a narrowing of the aortic valve that restricts blood flow), who are considered to be high risk for conventional open-heart valve replacement surgery (Medical Device Daily, March 22, 2007).

Earlier this year, Cook (Bloomington, Indiana) filed suit in D sseldorf district court in Germany against Edwards, claiming that Edwards' Sapien THV heart valve directly infringes on German Patent DE 60128069T2.

Cook asked the court to issue a cease-and-desist order to prevent Edwards from manufacturing, importing, exporting, or selling the device, and has asked for an accounting of all commercial activities for the infringing product and a judgment for damages (MDD, Feb. 4, 2008).