CardioKinetix Clears 2-Year Study with Implant for Heart Failure
CardioKinetix has spent 10 years and $80 million in venture capital working on an implantable device for people with heart failure. Now it’s got some evidence that suggests it could be on track with a real product.
The Menlo Park, CA-based company is announcing today it has passed a study of 31 patients who got an implantable device designed to help the heart beat more efficiently after the muscle is damaged by a heart attack. About 16 percent of the patients died or had to be hospitalized within one year of getting the heart failure implant, and 32.3 percent suffered that fate within two years.
The trial lacked a control group, so it’s impossible to directly compare how those patients would have done otherwise. But historic studies have shown that about 40 percent of patients can expect to die or be hospitalized after one year, and about 60-65 percent would normally end up that way on standard treatments, according to CardioKinetix’s executive director of therapy development, Barry Templin.
The findings, being presented today at the EuroPCR meeting in Paris, mean that CardioKinetix is now in position to see if its product can really pass muster in a more rigorous study of 500 heart failure patients in the U.S.—the kind of evidence it will need to win FDA approval. The CardioKinetix device isn’t intended to help all of the 2.5 million people worldwide diagnosed annually with different types of heart failure, but it could end up being a new option for about 20-30 percent of patients with a form of this chronic disease, Templin says.
“Our device isn’t just a quick fix, we’re seeing long term benefit,” Templin says. One of the study’s investigators, Marco Costa of the Interventional Cardiovascular Center at Case Western Reserve University, gushed in a company statement saying, “it is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population. The sustained and concordant improvements in symptoms, heart function, and clinical outcomes are compelling, with a very acceptable safety profile.”
Before diving in too deep into the details of this study, a little background is required on what CardioKinetix is attempting to do. The private company got its start in 2002, and has raised its cash from a well-known syndicate that includes SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. CardioKinetix has about 30 employees today, Templin says.
The big idea at CardioKinetix is to develop what it calls its Parachute Ventricular Partitioning Device. The way this works, a technician slides a narrow catheter into a patient’s femoral artery in the leg, threads it into the heart with the Parachute device tightly bound to the catheter. Once inside the heart’s left ventricle, the device gets popped open like a parachute, and it has tiny hooks on the edge that enable to to anchor itself in position in the heart muscle. The procedure is supposed to take 40-60 minutes.
Once the implant is in place, physicians hope to essentially wall off part of the heart muscle that gets loose and damaged after a heart attack, which makes it harder for the heart to pump blood in and out efficiently. Walling off part of the heart … Next Page »