A Medical Device Daily Staff Report

Abiomed (Danvers, Massachusetts) reported a strategic partnership with Opsens (Quebec) in which Opsens' sensor technology will be integrated into the Impella catheter to provide blood pressure measurements that can be used to enhance Impella's performance and ease-of-use.

Impella, a small heart pump, has supported more than 1,600 patients in the U.S. and more than 3,000 patients worldwide. Over the past fiscal year 2010, product enhancements to the Impella have included a new introducer sheath and a quick set-up software and kit, which have allowed customers to reduce the Impella set-up time from 11 minutes to two minutes.

Through this latest enhancement, Opsens' fiber optic sensors will be integrated into the Impella catheter and will allow for further improvements in set-up time, as well as provide a high-quality pressure monitoring capability that can eventually be used to help automate the control and operation of the Impella pump. Unlike current fiber optic sensors used on other cardiac assist devices today such as certain Intra-Aortic Balloons (IABs), Opsens' fiber optic sensor is designed to provide longer-term accuracy and reliability.

"This partnership with Opsens further demonstrates Abiomed's commitment to continue enhancing and updating Impella technology and providing better results for customers," said David Weber, COO of Abiomed. "By integrating Opsens' technology into our Impella platform, we can provide our customers with even more calculated control and insight during their high-risk and emergent procedures."

In other agreements/contracts news:

• Applied Biosystems and Idaho Technology (both Salt Lake City) have signed a cross-licensing agreement which covers a broad range of products including hardware, software and reagents.

The agreement includes patents relating to real-time polymerase chain reaction methods and instrumentation, including the 5' Nuclease process and the use of SYBR Green I in PCR reactions.

"This agreement demonstrates both companies' commitments to advancing quality research in the applied and life science fields. It also enables innovation in a more open environment that is good for business and ultimately benefits customers," said Randy Rasmussen, president of Idaho Technology.

The financial terms of the agreement will not be disclosed.

• Etex (Cambridge, Massachusetts) reported a distribution agreement with OrthoPediatrics (Warsaw, Indiana). OrthoPediatrics will market and sell Etex's nanocrystalline calcium phosphate on a non-exclusive basis in the U.S. and Canada.

The Etex bone graft portfolio complements pediatric orthopedic and spine surgery as illustrated in the recent publication of positive pediatric outcomes using Etex nanocrystalline calcium phosphate in the treatment of unicameral bone cysts.

EquivaBone is the first osteoinductive and osteoconductive product that is moldable, injectable and sets hard once implanted. A combination of Etex's osteoconductive nanocrystalline calcium phosphate and osteoinductive demineralized bone matrix, EquivaBone is indicated for use in posterolateral spine fusion. In addition, the osteoinductivity of the DBM is certified by lot in an in-vivo model, after sterilization, for the entirety of shelf life. Beta-bsm Injectable Paste and Gamma-bsm Moldable Putty set hard with high compressive strength and provide an optimal osteoconductive scaffold for new bone growth. The nanocrystalline formulation mimics the chemical structure of human bone resulting in a predictable remodeling rate.

All three Etex products are indication specific and intended for use in filling bone voids or defects of the skeletal system (including extremities, pelvis, and spine) that are not intrinsic to the stability of the bone structure.

• EmCare (Dallas), a provider of outsourced hospital-based emergency physician services, has partnered with The Studer Group (Gulf Breeze, Florida), an international outcomes based healthcare organization which assists hospitals in improving clinical and operational results through a focused strategy of evidence based tactics. Studer presently provides healthcare coaching to more than 1,000 hospitals. Combined with EmCare's experience, physician and nursing leadership, the partnership has the potential to positively affect millions of patients each year. Quint Studer, CEO and founder of The Studer Group, said, "Our mission is to make healthcare better for patients, physicians and employees. We see our partnership with EmCare as a shared goal to achieve the very best in emergency services across the country. Emergency care is often the first impression of a hospital and has a significant impact on its reputation."

• PeriGen (Princeton, New Jersey) has entered into an agreement with Beazley Group, a Lloyd's of London-based insurer of medical malpractice for U.S. hospitals. Beazley will provide insurance coverage at a reduced cost to hospitals that implement PeriGen's solution suite.

• Quantros (San Francisco), a provider of safety and quality software and professional services solutions for the healthcare industry, reported that Banner Health has adopted the Quantros RRM solution to manage its clinical improvement and regulatory reporting efforts. Banner Health is a non-profit hospital systems with 22 healthcare facilities across seven Western states. Quantros RRM is an electronic self-reporting system designed to streamline and simplify reporting to a number of state and national quality organizations.

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