From the annual meeting of the American College of Cardiology in Atlanta.
When a medical device tests safe and works well enough to cut patient mortality in half it usually has a rosy future. But not when the small-company developer falls victim to the recent financial crisis, an economic calamity that led to bankruptcy more than a year before the promising trial results were known.
The device was called Coapsys, and it had an unusual design: A piece of cord threaded through a patient’s left ventricle and tethered with two pads on either side of the heart (see photo). The idea was that the tension the cord exerted on the pads could reshape an enlarged heart to improve its function and partially correct mitral regurgitation, a leakage of blood through the valve that separates the left atrium from the left ventricle.
At the American College of Cardiology meeting last week, Dr. Eugene A. Grossi, a cardiothoracic surgeon at New York University, presented results from a multicenter, randomized trial that included 165 patients with enlarged hearts, heart failure, and functional mitral regurgitation. The device was safe, with none of the 81 patients who received it having a peri-operative complication. The device recipients also had significantly fewer adverse events during 3 years of follow-up. And their overall mortality rate was about half that of the 84 control patients, who had conventional surgical treatment of their mitral regurgitation.
After the company that developed the device and started the trial, Myocor, closed down in late 2008, a viable medical-device company, Edwards Lifesciences purchased the rights for the Coapsys device and all of Myocor’s other intellectual property. But a query today to a spokeswoman for Edwards revealed that the company had no specific, immediate plans for further development of the Coapsys device, or at least no plans that they were willing to reveal.
Despite Edwards’ suprising lack of enthusiasm, or at least expressed enthusiasm, Dr. Grossi remained optimistic that the new results will not be overlooked. “With something as concrete as a mortality benefit, I think we’ll see a lot of equivalent devices that focus on treating the ventricle and not the mitral valve,” he said.
—Mitchel Zoler (on Twitter @mitchelzoler)