Orqis Medical Corp. of Lake Forest, Calif., and Levitronix LLC of Waltham, Mass., make effective use of polycarbonate in a system proposed to treat patients with chronic congestive heart failure.
The system supplements the heart in pumping blood to the body.
Orqis sought guidance from Bayer MaterialScience LLC of Pittsburgh in selecting material for multiple components in its Cancion system. The answer was biocompatible Makrolon 2558 PC, an existing product Bayer markets for medical applications.
Advanced Technology Inc. of Corona, Calif., molds the system's critical catheter connections on an 80-ton press.
Levitronix also uses the material to make four parts that, with a magnet, are assembled to make the firm's CentriMag-brand centrifugal pump at the heart of the system. Two white PC components encase the magnet and create the pump's impeller. Two PC parts are bonded to form a clear chamber within which the impeller floats. A motor using electromagnetic forces levitates and rotates the impeller within the pump chamber.
Bayer recommended Makrolon 2558 for its clarity and biocompatibility, said Kevin Dunay, the resin supplier's medical market segment leader.
The U.S. Food and Drug Administration gave Orqis initial trial approval in 2004 and an unconditional authorization in 2005 to begin enrolling patients in as many as 40 domestic hospitals. Orqis may complete the U.S. clinical trial in August and seek full FDA approval, possibly by late 2008.
Outside the U.S., the device is available in certain European and Asian markets, said Robert Pecor, Orqis senior research and development engineer.
``This is a disruptive clinical technology in the area of acutely decompensated heart-valve therapy,'' said Ken Charhut, Orqis president and chief executive officer. It is ``an amazing product'' that may reduce high doses of medication that congestive heart failure patients experience. Orqis was formed in 1999 and employs 35.
Bayer discussed the project at the Medical Design and Manufacturing West trade show, Feb. 13-15 in Anaheim.
In other matters, Bayer MaterialScience introduced two additions to its Bayblend line-DP M850 and DP M850XF-as the company's first medical-grade PC/ABS blends. Dunay said Bayer developed the grades in the face of a need for engineering resins that balance processability and physical properties required for medical device and diagnostic equipment components.
Further, Bayer MaterialScience introduced a family of medical-grade Texin thermoplastic polyurethanes for use in catheters, flexible thin-walled kink-resistant tubing, connectors, puncture-resistant films and fabric coatings for breathable gowns, linens and wound dressings. The grades provide improved clarity and color that medical device developers require.
Also at the show, Deerfield Urethane Inc. of Whately, Mass., a Bayer MaterialScience subsidiary, introduced two grades in its Duraflex line of thermoplastic and specialty elastomer film and sheet.
Duraflex X2133, an elastic aromatic polyester PU film or sheet, is suitable for fabric apparel applications requiring elastic recovery or industrial uses requiring repeated, multicycle elongation. Duraflex X2140, an additive-free aromatic polyether PU film or sheet, can provide high slip and low gloss without blooming and is useful with adhesion or ink requirements.
Parent firm Bayer AG is based in Leverkusen, Germany.
