10.08.14
The first in-human use of Pittsburgh, Pa.-based CardiacAssist Inc.’s Protek Duo veno-venous extracorporeal life support (ECLS) kit was recently performed at Memorial Hermann Hospital in Houston, Texas. According to statements from the world-renowned heart failure team led by Biswajit Kar, M.D., Pranav Loyalka, M.D., and Igor Gregoric, M.D., the kit was used when one patient’s heart function continued to deteriorate despite the successful implantation of a long-term left ventricular assist device (LVAD).
The Protek Duo 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 liters 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 Kar, chief of the Medical Division Center for Advanced Heart Failure and professor of internal medicine at Memorial Hermann. “The Protek Duo performed well and we plan on making it a permanent part of our treatment arsenal.”
The Protek Duo veno-venous cannula recently received U.S. Food and Drug Administration 510(k) clearance as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during ECLS procedures. Upon clearance, CardiacAssist initiated a limited commercial release in September and expects to begin full commercial release before the end of the year.
“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.”
The Protek Duo 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 liters 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 Kar, chief of the Medical Division Center for Advanced Heart Failure and professor of internal medicine at Memorial Hermann. “The Protek Duo performed well and we plan on making it a permanent part of our treatment arsenal.”
The Protek Duo veno-venous cannula recently received U.S. Food and Drug Administration 510(k) clearance as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during ECLS procedures. Upon clearance, CardiacAssist initiated a limited commercial release in September and expects to begin full commercial release before the end of the year.
“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.”