Berkeley, California - Sunshine Heart Inc. has passed the five-year milestone on durability-testing of its C-Pulse implantable heart-assist device, according to a statement from the Polymer Technology Group Inc. (PTG)
PTG supplied two of its urethane-based biostable polymers for the C-Pulse, a spokesperson for the company confirmed.
The C-Pulse is designed to be a non-blood-contacting heart-assist therapy for treating patients with moderate to severe heart failure. In this condition, the heart progressively loses its ability to efficiently pump blood throughout the body.
Sunshine Heart wants to set up an IDE (Investigational Device Exemption) feasibility trial with C-Pulse, according to PTG, which says that, of the more than five million patients with heart failure each year in the US, 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, PTG adds. "C-Pulse is designed as a cost-effective device therapy to serve this substantial, unmet need - a potential $1400-million 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 of 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.
PTG specialises in research, development, design, scale-up, and manufacture of polymers, medical devices, and components. Its portfolio includes two extensively tested biomaterials for clinical use, BioSpan segmented polyurethane and Bionate polycarbonate urethane.
The company also offers components custom-fabricated from its patented PurSil silicone polyether urethane and CarboSil silicone polycarbonate urethane. PTG's recently expanded operations to 53 000-sq.ft (5000- sq.m) house the equipment and expertise to support production-scale polymer synthesis through contract medical device manufacturing.