Abbott (Abbott Park, Illinois) reported signing an agreement with Blood Systems Laboratories (Scottsdale, Arizona) to supply its Prism System automated blood screening instruments and assays at Blood Systems' U.S. blood donor testing sites. The agreement runs through 2011. Financial terms were not disclosed.

• Cordis (Miami Lakes, Florida) reported that it has signed an agreement to become the worldwide distributor of Brivant’s (Galway, Ireland) advanced guidewires, used to place catheters and drug-eluting stents in a patient’s coronary system. The wires can also be used for products targeting the peripheral system. The three products covered under this agreement include a general-purpose guidewire, a guidewire targeted for highly stenosed lesions and a specialty J-tip guidewire used to navigate challenging anatomies. Cordis will market these guidewire products under an umbrella brand known as Regatta. Cordis is a Johnson & Johnson (New Brunswick, New Jersey) business.

The FDA in late September unveiled a partnership, under the agency’s Critical Path Initiative, with Duke Clinical Research Institute (DCRI; Durham, North Carolina) to develop a tool to identify, as early as possible, the potential effects that drugs and devices may have on the heart. The agency said the research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) collected by the agency from clinical trial data submitted for drug applications. “For years we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient’s heart,” said Andrew von Eschenbach, MD, acting commissioner. “Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005 and this partnership in 2006, we are now able to identify biological measures that will help to predict which patients are at an increased risk for cardiovascular side effects.” Among the first applied projects that the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study. Duke and FDA researchers, together with their consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques — to select the most efficient methods — to searching for novel ECG waveform features capable of detecting small adverse drug effects.

• GE Healthcare (Waukesha, Wisconsin) and St. Jude Medical (St. Paul, Minnesota) reported an agreement to develop an integrated imaging/monitoring capability to cardiac catheterization labs. The companies will develop a cardiovascular ultrasound imaging system with fully integrated intracardiac echocardiography (ICE) imaging capabilities, for use in treating heart disease. GE's ultrasound technology will be integrated with St. Jude's catheter technology for real-time ultrasound imaging inside the heart, with direct visualization of both blood flow and other catheters used during cardiac procedures. The combined imaging technology is expected to give physicians high-quality diagnostic images of cardiac structures and blood flow throughout the heart. Dr. Laurence Epstein, chief of the Cardiac Arrhythmia Service at Brigham and Women's Hospital (Boston). "The development of ICE technology has changed how we approach ablation procedures. We can visualize, in real time, the actual anatomic structures that we are targeting." Laura King, global vice president, Interventional Cardiology, said that the company’s products “are utilized in 112 of the 120 electrophysiology teaching institutions today.” She said the agreement focuses on delivering the latest technologies to electrophysiologists.

• MedCath (Charlotte, North Carolina) and Benefis Healthcare (Great Falls, Montana) reported that they will end their alliance, entered into in June 2005 with the intention of jointly working to evaluate the expansion and growth of Benefis’ cardiovascular services through an equity arrangement. The companies said the alliance will terminate on or about Dec. 31. “When we entered into this agreement more than a year ago, we both understood that this was a complex arrangement that had many moving parts. In the end, some of these caused both of us to conclude that converting the management agreement to an equity partnership did not fit either of our strategic ambitions,” said Ed French, MedCath’s president/CEO. He said that the decision to end the agreement was done by the two companies “on good terms.” MedCath has been managing Benefis’ cardiovascular services and working with Benefis on design and development stages for a new patient tower that will include four floors dedicated to heart care. The concept includes an opportunity for MedCath to invest equity into the physical plant and operations. Benefis is a regional health system focused on the diagnosis and treatment of cardiovascular disease. It owns interests in and operates 11 hospitals in Arizona, Arkansas, California, Louisiana, New Mexico, Ohio, South Dakota, and Texas.

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