Startup CardioKinetix has reported positive pivotal data from China on its catheter-based heart failure treatment, the Parachute Ventricular Partitioning Device. It expects these study results to support a regulatory submission with the China Food and Drug Administration (CFDA).
The device is also in an ongoing U.S. pivotal trial that is currently enrolling. It's slated to be a randomized, open-label trial to treat congestive heart failure due to left ventricular systolic dysfunction in 560 patients. The U.S. trial is expected to have final data for the primary endpoint of death or rehospitalization due to worsening heart failure after at least one year in June 2016, although the trial will be ongoing until June 2020. The trial started enrolling patients in December 2012.
To finance all this clinical trial activity, CardioKinetix got a $50 million cash infusion in December led by Edwards Lifesciences ($EW) that included U.S. Venture Partners, Tekla Healthcare Investors, Tekla Life Sciences Investors, SV Life Sciences, Panorama Capital, New Leaf Venture Partners and Lexington Private Equity. The Parachute Ventricular Partitioning Device received CE Mark in 2011
More importantly, Edwards gained the right to acquire CardioKinetix based on undisclosed regulatory milestones at same time as the recent financing.
The China trial in 31 patients found that the left ventricular end systolic volume index reduction as compared to baseline fell from 78.2 ± 20.3 ml/m2 at baseline to 53.4 ± 17.4 ml/m2 at three-month follow-up. This was the primary endpoint.
"The results of this study, which met its primary and secondary endpoints, continue to substantiate the safety profile and effectiveness of the Parachute as a viable minimally invasive ventricular partitioning device for patients with ischemic heart failure," Dr. Gao Runlin, chief cardiologist at Fu Wai Hospital, Chinese Academy of Medical Sciences and co-principal investigator of the trial, said in a statement.
The clinical trial had a major adverse cardiac event rate of 3%. The study results were analyzed at a Yale echocardiography core lab. The study enrolled patients that were class II according to the New York Heart Association classification system for heart failure, patients with cardiac disease that slightly limits their physical activity but who are comfortable at rest. Ordinary physical activity causes these patients to exhibit symptoms including fatigue, palpitation, dyspnea or anginal pain.
"The Parachute China trial is the fourth trial to demonstrate statistically and clinically meaningful results from our clinical program," Maria Sainz, president and CEO of CardioKinetix, said in a statement. "We are highly encouraged by the Chinese investigators' enthusiasm for the Parachute device where already more than 50 patients have been treated through clinical trials or special access programs from nine hospitals."
- here is the release
Special Report: FierceMedicalDevices' 2012 Fierce 15 - CardioKinetix