A Medical Device Daily

Cardiac Science (Bothell, Washington) has signed an amendment to its agreement with GE Healthcare (Waukesha, Wisconsin) which extends the agreement's term to five years from the original three years.

GE Healthcare, a division of General Electric (Fairfield, Connecticut), will cell Cardiac Science's "crash cart" defibrillator/monitor to hospitals in the U.S. and Canada under Cardiac Science's Powerheart brand, and to customers outside North America under the GE Responder brand.

GE and Cardiac Science said they have partnered to refine the product specifications and features to ensure successful launch. Arrangements were also made to support GE's worldwide service model. Product shipments are being made under a pilot program.

The defibrillator/monitor is a rugged portable device with resuscitation and pacing therapies for use by professionals. The pilot program tests the worldwide logistics of the product launch by shipping finished devices to customers as well as service kits to GE service centers. Full shipments will begin upon the completion of the pilot program.

"GE's global presence in hospitals, physicians' offices and clinics, combined with world-class products from Cardiac Science, positions us to establish a leadership role in providing defibrillation technologies to healthcare providers," said Matthias Weber, MD, GE Healthcare's vice president and general manager, Diagnostic Cardiology.

In other agreement news:

• CryoLife (Atlanta), a biomaterials and biosurgical device company, has signed a licensing/distribution agreement with BioForm Medical (San Mateo, California), for CryoLife's BioGlue Surgical Adhesive for use in cosmetic and plastic surgery indications.

BioGlue is a two-component adhesive that creates a flexible, mechanical seal in 20 to 30 seconds and reaches maximum bonding in two-three minutes. BioGlue is approved in the U.S. as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE-marked and approved in Canada and Australia for cardiac, vascular, pulmonary and other soft tissue repair.

BioForm will pay for clinical development and regulatory approval process for BioGlue for use in cosmetic and plastic surgery in the U.S., Canada and various countries in Europe. CryoLife will receive an initial fee from BioForm, as well as a milestone payment upon the first FDA approval for use in cosmetic and plastic surgery indications.

BioForm will be responsible for precommercialization activities involving the use of BioGlue in cosmetic and plastic surgeries, including all clinical trials and regulatory filings for the U.S., Europe and Canada. In addition, the company will oversee all aspects of the marketing, sales and distribution of BioGlue on a worldwide basis for these indications. CryoLife will remain the exclusive supplier of BioGlue for all applications.

• Mentor (Santa Barbara, California) has entered into a commercialization pact with Genzyme (Cambridge, Massachusetts) for Genzyme to develop future hyaluronic acid (HA) dermal filler products. Terms of the agreement were not disclosed.

The first product launch under the agreement is scheduled to occur internationally in early 2007, with worldwide launch of an additional product in late 2007. Under the agreement, Genzyme and Mentor will partner to develop a next-generation, longer-lasting HA dermal filler.

Mentor makes products for surgical and non-surgical medical procedures designed to allow patients to retain a more youthful appearance. Its products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing.

• Misys Healthcare Systems (Raleigh, North Carolina) reported a partnership with mTuitive (Centerville, Massachusetts) to better ensure the accuracy of cancer diagnosis in anatomic pathology laboratories.

mTuitive develops software designed to assist healthcare professionals in recording clinical findings according to established protocols and guidelines, to provide a structured data reporting (synoptic analysis) solution for anatomic pathology laboratories. "Together, Misys and mTuitive will bring anatomic pathology reporting to a new level by providing clinicians with the most advanced laboratory tools to distinguish clinical findings and ultimately optimize patient care," said Richard Atkin, president of Misys Healthcare Systems Hospital System business unit.

"Our partnership with Misys and its laboratory products helps to provide the best care and treatment options to patients," said John Murphy, CEO of mTuitive. "Surgical pathologists are required to report an increased amount of clinically significant findings. This partnership helps meet the definitive need for a standardized terminology pathology report to clearly pinpoint the most important findings, communicate results among pathologists, oncologists and surgeons, and to quickly and accurately determine the proper treatment."

Misys Healthcare develops and supports software and services designed to enable physicians and caregivers to more easily manage the complexities of healthcare.