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TandemLife is now a part of LivaNova, Learn More Here.

COVID-19 UPDATES:The U.S. Food and Drug Administration (FDA) issued guidance on April 6, 2020 to temporarily expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address the novel coronavirus (COVID-19) public health emergency. As a result of the guidance, cardiopulmonary devices, including select devices from TandemLife | LivaNova, are now temporarily indicated for ECMO therapy greater than 6 hours. To read the full announcement, click here.



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CardiacAssist Announces the First Human Use of Its PROTEK DUO™ Veno-Venous ECLS Kit

Posted on March 23, 2016 | News & Press

Texas man is the world’s first to receive the PROTEK Duo for treatment following surgery

CardiacAssist, Inc. today announced that the first PROTEK Duo veno-venous extracorporeal life support (VV ECLS) kit was utilized on Wednesday, September 24th, at Memorial Hermann Hospital in Houston, Texas. According to statements from the world-renowned heart failure team led by Dr. Biswajit Kar, Dr. Pranav Loyalka and Dr. Igor Gregoric, the PROTEK Duo ECLS kit was utilized 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 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.”

The PROTEK Duo veno-venous cannula recently received FDA 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.”