Biomaterials Leader Polymer Technology Group (PTG) Says Sunshine Heart's C-Pulse(TM) Implantable Heart Assist Device, Made from Two PTG Polymers, Has
BERKELEY, Calif. (Business Wire EON) April 16, 2008 -- 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(R) segmented polyurethane and Bionate(R) polycarbonate urethane. In addition, PTG offers custom-fabricated components from its patented PurSil(R) silicone polyether urethane and CarboSil(R) 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.