• Biopure (Cambridge, Massachusetts) reported completing enrollment in the Phase II human clinical trial in Europe evaluating the safety and feasibility of its investigational oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)] in patients undergoing elective coronary angioplasty. Generation of trial data, it said, will conclude at the end of April after all enrolled patients complete a 30-day follow-up period. Biopure said it is hopeful that the clinical trial investigators will be able to present preliminary results in May at the late-breaking session of the EuroPCR conference in Paris. The clinical trial was designed as a randomized, double-blind, dose-finding, multi-center study to assess the safety and feasibility of Hemopure in patients with coronary artery disease. In related preclinical research published in the April issue of the American Journal of Physiology - Heart and Circulatory Physiology, researchers at Louisiana State University (New Orleans) reported the results of an animal study of Hemopure in an article titled "A novel hemoglobin-based blood substitute protects against myocardial reperfusion injury."

• CHF Solutions (Brooklyn Park, Minnesota) reported the launch of the Aquadex FlexFlow System, its next-generation technology used to treat fluid overload in patients with renal failure, post-surgical fluid overload, metabolic disease or congestive heart failure. The new system offers greater flexibility and precision in setting blood-flow and fluid-removal rates, the company said. It is introducing the Aquadex FlexFlow at the annual conference of the International Society for Heart and Lung Transplantation (Addison, Texas) this week in Philadelphia. The Aquadex FlexFlow is used to perform Aquapheresis, a procedure to safely and predictably remove excess salt and water from fluid-overloaded patients. With the system, physicians have more choices in venous access sites and expanded catheter capability, CHF said.

• Criticare Systems (Milwaukee) reported introduction of the Veris MRI monitoring system, a joint development effort with Medrad (Indianola, Pennsylvania). This program began in 2003 as a multi-year agreement with the goal of developing an advanced monitoring system specific to MRI applications. Veris is the first MR monitor with five-lead ECG waveform monitoring and is compatible with 3T MRI environments. The system brings an array of features and accessories, including those designed for pediatric and neonate patients, to MRI environments of up to 3T. Veris can also be equipped with gas technology through the integration of the Criticare respiratory analyzer. It is available in six configurations to meet specific customer needs for anesthesia, sedation, cardiac MR, research and basic patient monitoring.

• EPIX Pharmaceuticals (Cambridge, Massachusetts) reported initiation of a Phase II proof-of-concept trial for EP-2104R, its injectable MRI agent designed to detect blood clots throughout the body. In a Phase I trial, completed late last year, EP-2104R was well-tolerated by healthy subjects at all doses. The Phase II proof-of-concept program is being conducted at multiple sites worldwide to further test safety and test preliminary efficacy of EP-2104R for the evaluation of blood clots in patients presenting with strong suspicion of clots from thrombo-embolic disease. EP-2104R-enhanced MR imaging will be compared to other diagnostic imaging tests to determine the location and size of blood clots. About 40 patients are expected to be enrolled in the trial. EPIX is collaborating with Schering (Berlin) in the development of EP-2104R.

• Novare Surgical Systems (Cupertino, California) reported receiving FDA clearance to market its family of EndoLink surgical instruments, the first single-use, handheld instruments to incorporate six degrees of articulating freedom, it said. Comprised of grasper, dissector, needle drive and scissors, the instruments are used in laparoscopic surgery to enable minimally invasive approaches in gastric bypass, cardiac bypass, pulmonary lobectomy and general and urologic procedures. According to Kerry Pope, Novare president and CEO, the EndoLink system offers enhanced anatomical access and device control not available with traditional straight laparoscopic instruments. "Our novel system can be incorporated into instruments as small as 3 millimeters and enable articulation similar to a human wrist. This gives the surgeon greater control and access that can provide important gains in minimally invasive surgery."