U.S. regulators have given premarket approval to a streamlined, programmable and implantable drug-delivery pump to treat and manage back pain, the first new development in such pumps since a device from Medtronic (NYSE:MDT) hit the market more than 15 years ago.
The Prometra drug-delivery pump has been approved for use with Infumorph, a pain medication. It uses pressure differentials in order to optimize accurate drug delivery. The pump has no motors or tubing and few movable parts. It is implanted under the skin in the lower abdominal area with a catheter that goes from the pump to the spine, according to Steve Adler, Medasys chief executive and developer of the pump.
The drug-delivery pump is Medasys’ first product to be approved by the U.S. Food and Drug Administration. The six-year-old medical device company based in Mount Olive, New Jersey received approval from European regulators for the pump in December 2010. It is closely partnered with Massachusetts-based Proven Process Medical Devices.
Typically, there are about 40,000 drug-pump implants each year, said Adler. The target market is cancer patients and people who suffer from chronic intractable pain. The company is currently seeking investment to bring the product to market and develop other applications for the pump. It has received funding to date from private angel investors as well as from institutional investor Clarus Ventures.
Adler sees quite a few applications for the implantable drug pump such as for treating spasticity, a secondary disorder related to multiple sclerosis or a spinal cord injury, epilepsy, Alzheimer’s disease and Huntington’s disease.
