Technology | September 05, 2014

Protek Duo Veno-Venous Cannula Receives FDA 510(k) Clearance

September 5, 2014 — CardiacAssist announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Protek Duo veno?venous cannula. The Protek Duo is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support (ECLS) procedures.

According to estimates from the National Heart, Lung and Blood Institute (NHLBI), approximately 190,000 Americans are affected by acute respiratory distress syndrome (ARDS) every year. Despite receiving therapy with mechanical ventilation, which is widely considered the standard of care, approximately 40 percent of patients diagnosed with ARDS will die as a result of the disease.

Veno?venous extracorporeal life support (VV ECLS) is an emerging therapy designed to provide a higher level of support by infusing oxygen directly into the blood using an oxygenator. In one large randomized, controlled clinical trial of 180 adult ARDS patients, the use of advanced VV ECLS therapy was shown to reduce the rate of death and disability by 31 percent compared to conventional management with mechanical ventilation.

The Protek Duo cannula is designed to address two major roadblocks that have prevented VV ECLS therapy from becoming a new standard of care: the difficulty of initiating and maintaining a patient on VV ECLS support, and suboptimal gas exchange rates with currently available devices. Insertion of the Protek Duo cannula can be performed through a minimally invasive percutaneous procedure, and patient management is simplified by combining with the lightweight and compact TandemHeart pump, which can be placed directly on the patient.

The TandemHeart platform is designed to simplify patient ambulation and enable freedom of movement not possible with mechanical ventilation or any alternative ECLS device. “The percutaneous internal jugular approach of this promising new technology will give us the ability to minimize the morbidity usually associated with central ECLS cannulation. By optimizing patient mobility, we also expect to reduce the long-term negative effects of severe deconditioning. The ECLS community welcomes these innovative medical devices designed to help physicians improve patient outcomes,” said Jose P. Garcia, M.D., surgical director of cardiothoracic transplantation and the Artificial Heart & Lung Program at Massachusetts General Hospital in Boston.

“TandemHeart has been focused on the treatment of heart failure since the company’s inception in 1996. The U.S. launch of Protek Duo with our TandemHeart platform is propelling our company into a new era, creating innovative products for both heart and respiratory failure. This will mark our third product launch in the past year, and we are excited and proud to be launching many more new products over the next 12 months,” said John Marous, president and CEO of CardiacAssist.

For more information: www.cardiacassist.com

Related Content

Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD) | May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
Videos | Ventricular Assist Devices (VAD) | April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Henry Ford Hospital, Detroit Cardiogenic Shock Initiative, Impella pump, ACC.17 clinical study
News | Ventricular Assist Devices (VAD) | April 03, 2017
Hospitals can dramatically increase heart attack survival rates in patients suffering cardiogenic shock by providing...
Metro Detroit cardiologists, increased heart attack survival rate, Impella heart pump, Detroit Cardiogenic Shock Initiative
News | Ventricular Assist Devices (VAD) | March 09, 2017
Metro Detroit cardiologists from five health systems have joined together to increase residents’ survival rate from...
Impella 2.5 heart pump, high-risk PCI, HRPCI, acute kidney injury risk, AKI, Circulation Research study, Abiomed
News | Ventricular Assist Devices (VAD) | March 09, 2017
A new study published in Circulation Research finds use of hemodynamic support with the Impella 2.5 heart pump during...
James Ward, LVAD surgery, left ventricular assist device, UAB, University of Alabama at Birmingham
News | Ventricular Assist Devices (VAD) | March 08, 2017
Congestive heart failure patients at the University of Alabama at Birmingham (UAB) now have reason for optimism with a...
Overlay Init