CardiacAssist, Inc. has announced that its PROTEK Duo veno-venous extracorporeal life support (VV ECLS) kit has been used in a human for the first time. The case took place at the Memorial Hermann Hospital in Houston, Texas.
The PROTEK Duo veno-venous cannula recently received U.S. FDA 510(k) clearance as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during ECLS procedures. Following clearance, CardiacAssist initiated a limited commercial release in September and now says it expects to begin full commercial release before the end of the year.
The PROTEK Duo ECLS kit was reportedly utilized when a patient’s heart function continued to deteriorate despite the successful implantation of a long-term left ventricular assist device (LVAD). The cannula was placed during a short, minimally-invasive percutaneous procedure in the cardiac catheterization lab before returning the patient to the hospital’s cardiac intensive care unit, where many of the pharmaceuticals upon which the patient was dependent were able to be weaned. In combination with the TandemHeart® pump, the PROTEK Duo was reported to deliver 4.0 Litres per minute of blood flow, allowing the patient’s native heart to rest while augmenting flow to the implantable LVAD. The patient is now in the process of being weaned from the device and the outlook is favorable despite a long road to full recovery.
“Our team prides itself on our ability to offer patients the most advanced treatment options and technologies. On behalf of the entire team, I’d like to say that we are very proud to be the first center to use the PROTEK Duo as this technology provides a new opportunity to support a group of patients that previously had few alternatives,” said Dr. Biswajit Kar, Chief of the Medical Division Center for Advanced Heart Failure and Professor of Internal Medicine at Memorial Hermann Hospital. “The PROTEK Duo performed well and we plan on making it a permanent part of our treatment arsenal.”
“I would like to congratulate our team for bringing this revolutionary product through development and into commercial launch in record time,” said John Marous, President and CEO of CardiacAssist. “We are extremely happy with PROTEK Duo’s performance in the first of many opportunities to help patients in need.”
Source: CardiacAssist, Inc., Business Wire