Pelham, a medical device manufacturer located in Pelham, N.H., has been contracted to produce the company's Phase One's new Reversus hemodialysis catheter, for which the company is currently pursuing FDA clearance.
Intended to provide long-term vascular access for hemodialysis treatment, the Reversus is designed to offer high flow rates, low recirculation and no loss of performance upon reversal of the hemodialysis lines, according to Hingham, Mass.-based Phase One.
Catheters are an essential vascular access option for a large percent of the worldwide hemodialysis population. Approximately 2 million patients worldwide receive hemodialysis three times a week. Hemodialysis requires access to a patient's vascular system. It's estimated that up to 30 percent of those patients receive their vascular access through the use of chronic hemodialysis catheters, according to figures released by Phase One.
Company officials noted that reversing the lines is necessary in 20-30 percent of catheter-based hemodialysis treatments making equal line function critical to achieving optimal dialysis results. c catheter use.
Phase One expects Reversus to receive FDA clearance in early 2013 and will initiate a commercial launch shortly thereafter. Phase One Medical has created a successful track record of developing and licensing endovascular devices. The launch of the Reversus will be the company's first commercial product launch. According to the company, this is a significant milestone as Phase One Medical transitions from an R&D only company to one that develops and commercializes innovative medical devices.
"We are excited to be working with Pelham Plastics to scale-up production of our hemodialysis catheter," said Don Woods, partner Phase One Medical. "We have worked with Pelham before and it was an easy choice to go back. They offer highly trained and experienced manufacturing engineers who have historically provided high quality and reliable products at a competitive price. This also aligns with our commitment to select and work with U.S.-based manufacturing partners."
The feeling from Pelham Plastics is mutual.
"We are pleased to be working with Phase One Medical again," said John Mackey, president of Pelham Plastics. "We specialize in manufacturing innovative high-end medical devices like the Reversus. We look forward to supporting Phase One Medical as they prepare to commercialize this exciting technology."
Phase One Medical is a privately held medical device research and development company focused on early stage development and small part design and manufacture. The company has made the strategic decision to commercialize devices developed in house.
The company is currently focused on development of chronic hemodialysis catheters that will improve product performance and most importantly begin to reduce the high rates of complications and cost associated with catheter use.