Sunshine Heart's C-Pulse™ Implantable Heart Assist Device, Made From Two PTG Polymers Passes 5-year Durability Testing

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 17 Apr 2008 - 5:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The Polymer Technology Group (PTG), a preeminent biomaterials company, announced today that its customer, Sunshine Heart Inc., has passed the five-year milestone on durability-testing of its C-Pulse™ implantable heart assist device. C-Pulse is designed to be a non-blood-contacting heart assist therapy for treating patients with moderate to severe heart failure, a condition in which the heart progressively loses its ability to efficiently pump blood throughout the body. C-Pulse includes two polymers from PTG.

Sunshine Heart is seeking to initiate an IDE (Investigational Device Exemption) feasibility trial with C-Pulse. Of the more than five million patients with heart failure each year in the United States, about 1.4 million of them have "Class III" or moderate heart failure. These patients are debilitated with a poor quality of life, despite optimum medical management. C-Pulse is designed as a cost-effective device therapy to serve this substantial, unmet need-a potential $1.4 billion annual market, according to Sunshine Heart.

"We started with PTG with an exploratory development program, then advanced to a manufacturing program, resulting in a very durable Cuff for the C-Pulse," said Donald Rohrbaugh, CEO, Sunshine Heart. "PTG is a great partner."

"We are very pleased to be partnering with an exceptional emerging company like Sunshine Heart, because there is a dire need for an innovative therapy to treat the growing epidemic that is moderate heart failure," added Bob Ward, CEO of PTG.

Polymer Technology Group (PTG) was co-founded in 1989 by Robert S. (Bob) Ward, who is a recognized pioneer in the field of biomaterials and the Company's CEO. PTG specializes in the research, development, design, scale-up, and manufacture of new polymers, medical devices, and components. PTG's commercial product portfolio also includes two of the world's most extensively tested biomaterials in clinical use today, BioSpan® segmented polyurethane and Bionate® polycarbonate urethane. In addition, PTG offers custom-fabricated components from its patented PurSil® silicone polyether urethane and CarboSil® silicone polycarbonate urethane. PTG's recently expanded operations to 53,000-square-feet comprise the equipment and expertise to support production-scale polymer synthesis through contract medical device manufacturing.

Polymer Technology Group