A Medical Device Daily

Coherex Medical (Salt Lake City) has entered into a multi-year distribution agreement with Abbott (Abbott Park, Illinois) for the Coherex FlatStent EF PFO Closure System.

The Coherex FlatStent EF device is designed to close Patent Foramen Ovale (PFO), a common structural heart defect found in about 20% of the worldwide population, using a percutaneous catheter-based approach. Some patients with clinical conditions including stroke and chronic migraine may benefit from PFO closure.

Coherex will provide marketing, sales and distribution rights to Abbott for the CE-marked Coherex FlatStent EF in all countries worldwide except for the U.S. and Japan. Coherex Medical will manufacture the Coherex FlatStent EF PFO Closure System at its facility in Salt Lake City. Financial terms of the agreement were not released.

Coherex reported in July that its Coherex FlatStent EF PFO Closure System had received CE mark clearance for closing PFO, making it the first "in-tunnel" device to be granted clearance by any regulatory body. With CE mark clearance, the Coherex FlatStent can be marketed and sold in more than 25 countries in Europe, as well as other countries outside of Europe. Coherex plans to conduct additional clinical trials in the future, designed to lead to eventual approval in the U.S. and Japan.

In other agreements and contracts news:

• Celera (Alameda, California) and Medco Health Solutions (Franklin Lakes, New Jersey) reported that they have entered into a research collaboration to evaluate whether testing for a gene variant called KIF6 increases patient adherence with statin therapy. Current studies have suggested that only about 50% to 60% of the patients who receive a prescription for a lipid-lowering drug are taking the medication after six months. This level of adherence falls to 30% to 40% after two years in patients with coronary artery disease. "A study of this nature has the potential to show that understanding your genetic risk can improve statin adherence," said Medco VP of Personalized Medicine Research and Development Felix Frueh. "Medco's research partnership with Celera could help provide more evidence that personalized medicine can improve patient outcomes." As part of this collaboration, the companies will conduct a prospective, randomized, open-label, multi-center study (AKROBATS – Additional KIF6 Risk Offers Better Adherence to Statins) to address the primary question of whether patient adherence with newly prescribed statin therapy is higher in those patients tested for KIF6 status than in those who are not offered the test.

• Midwest Ultrasound (Cincinnati, Ohio) has entered into a two-year renewable partnership with Toshiba America Medical Systems (Tustin, California) in which Midwest purchased an initial 11 Xario XG ultrasound systems to be used at The Christ Hospital (Cincinnati, Ohio) and with various other clients.

• Apollo Health Street (Conshohocken, Pennsylvania) and gloStream (Bloomfield Hills, Michigan) reported a new partnership in which Apollo Health Street will make its services available to gloStream's national network of technology partners. Apollo's services are an additional option for gloStream partners who wish to supplement their support services. Apollo Health Street's IT services offer a single point of contact for all technical support of gloStream's products and solutions, which are the only ones on the market embedded with Microsoft Office.

• Aspyra (Westlake Village, California) has contracted with Renaissance Radiology Medical Group (Pomona, California) to provide Aspyra's integrated AccessRAD RIS/PACS solution. Renaissance Radiology performs approximately one million studies per year, providing a full array of advanced medical imaging technologies. "Because we deal with a large volume of examinations from multiple locations everyday, it was important to us that we selected an integrated RIS/PACS vendor that was able to not only deliver the images to the radiologists consistently and seamlessly, but allow a level of customization that insured the right films were reaching the right radiologists and that they could be viewed according to the individual physician preferences," said Monika Kief-Garcia, CEO for Renaissance Radiology Medical Group. "The added ability to track and trend workflow from sites and referring physicians and facilitate billing was a dream come true to the office staff. Aspyra was able to demonstrate what no other vendor could."

• Practice Fusion (San Francisco) reported a partnership with BioReference Laboratories (Elmwood Park, New Jersey) in which the companies will collaborate to distribute Practice Fusion's EHR to interested BioReference physicians and will integrate BioReference lab results into the Practice Fusion's system. Practice Fusion's EHR includes charting, e-prescribing, scheduling, integration with billing systems, along with free training and support.

• InfoLogix (Hatboro, Pennsylvania) has been awarded a contract by Albert Einstein Healthcare Network (Philadelphia) to develop web-based eLearning software to support a large-scale EMR implementation. As Albert Einstein Healthcare Network prepares to roll out 17 modules of the Cerner Operating System across multiple facilities, InfoLogix eLearning will be developing customized web-based software to support the successful EMR implementation, training and adoption across the Albert Einstein network. The engagement is estimated to last about six months.