CardioKinetix targets FDA approval with heart-failure device trial
|CardioKinetix has enrolled its first patients in a pivotal trial of Parachute, a minimally invasive treatment for heart failure--courtesy of CardioKinetix|
CardioKinetix, a 2012 Fierce 15 winner, has launched a pivotal trial for its Parachute Ventricular Partitioning Device, planning to amass enough data to get the minimally invasive heart failure treatment on the market in the U.S.
The company has begun enrollment for a 500-patient study that will compare Parachute to standard therapies in people with ischemic heart failure, measuring all-cause mortality and repeat hospitalization.
The FDA approved plans for a pivotal trial a few years ago, but CardioKinetix wanted to wait until it had snagged enough venture funding to conduct a large, multi-center study, and a $44 million Series E apparently did the trick. Now, CEO Maria Sainz said, the company is ready move forward and start tracking toward FDA approval.
"We are excited about the opportunity before us to make a major positive impact for patients with heart failure, and we believe that we have partnered with the right heart failure physicians and interventional cardiologists to enroll this trial quickly," Sainz said in a statement.
Parachute is a first-of-its-kind treatment for heart failure, an umbrella-shaped implant that partitions off the damaged portion of the heart to restore the shape and function of the heart's left ventricle. The device is inserted through a catheter in the femoral artery, eschewing the need for large-scale surgery present in other ventricular-assist technologies.
To date, the company has raised about $81 million in venture financing from the likes of U.S. Venture Partners, Panorama Capital and H&Q Capital Management. Also among CardioKinetix's backers is heart-device heavyweight Edwards Lifesciences ($EW), but Sainz told FierceMedicalDevices back in October that the company is currently committed to staying independent.
- read the announcement
Special Report: CardioKinetix – 2012 Fierce 15