• Abiomed (Danvers, Massachusetts) reported peer-reviewed data on the Impella Recover LP 2.5 in the April issue of the American Journal of Cardiology. The study included 19 patients with high-risk percutaneous coronary interventions (PCI) and who were poor candidates for surgery. The study concluded that the device successfully supported 100% of patients undergoing elective high-risk PCI procedures; there were no significant device-related adverse events; no aortic valve regurgitation during device operation; no strokes; no limb pain or ischemia; and no post procedure complications. The Impella Recover LP 2.5 can deliver in excess of 2.5 liters of blood per minute and actively unloads the ventricle, increasing the cardiac output and both coronary and end-organ perfusion.

• DOBI Medical International (Mahwah, New Jersey) said it will feature its latest Dynamic Optical Breast Imaging (DOBI) technology, the ComfortScan system, at the 36th Jornada Paulista de Radiologia, which begins Thursday in Sao Paulo, Brazil. The ComfortScan system is an investigational optical imaging system that uses high-intensity, light-emitting diodes and gentle external pressure to highlight areas with vascular abnormalities in the breast, or tumor angiogenesis, often associated with cancer. The ComfortScan system is designed to be used along with mammography to improve the diagnosis of breast cancer.

• LMS Medical Systems (Montreal), a healthcare technology company and developer of the CALM (Computer Assisted Labor Management) system, reported that it has received FDA clearance to market its CALM Curve risk management tool in a standalone fashion, independent from previously prerequisite supporting platforms and infrastructure. CALM Curve will be available in the second half of 2006 through a seamless web offering, entirely independent of hospital computer infrastructure, in addition to already being integrated in the CALM clinical information system. CALM Curve is a computerized method of providing consistent and objective evaluation of a woman's labor progress.

• MedicalCV (Minneapolis), a cardiovascular surgery company, reported that it has received its third 510(k) clearance from the FDA stating that its Atrilaze Surgical Ablation system is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures. The latest clearance is for the 1064 nm wavelength laser technology, and complements its existing 810 nm wavelength laser technology. The company said the new clearance increases the functionality of the AtriLaze system allowing for further optimization and miniaturization, two characteristics required for a true, minimally invasive approach for treating atrial fibrillation.

• Scandius BioMedical (Littleton, Massachusetts), which makes products for the orthopedic sports medicine market, reported the release of the TriTis Tibial Fixation System, designed to give orthopedic surgeons a stronger tibial fixation solution for anterior cruciate ligament (ACL) reconstruction. The TriTis system provides strength through a cleat for tissue compression in the bone tunnel, an off-axis fixation screw to anchor the device, and a fixation washer to capture graft limbs and prevent graft slippage. The system also introduces new, easy to use instrumentation that allows the surgeon to feel compression in the tunnel based on the patient's anatomy, rather than estimating based on a sizing chart. The TriTis system is available in a range of implant size choices.

• St. Jude Medical (St. Paul, Minnesota) reported the implant of the first patient in its ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) migraine trial. The first implanted patient, a 53-year-old woman from Virginia, is one of about 500 patients who are expected to participate in the study. The trial will explore the link between patent foramen ovale (PFO) and migraine headaches to determine if closing the PFO reduces the frequency of migraine attacks. The patient was implanted with the company's Premere PFO Closure System, specifically designed for PFO closures and was part of the product portfolio acquired by the company through the 2005 acquisition of Velocimed.

• Synovis Life Technologies (St. Paul, Minnesota) reported the publication of an article in the April issue of the Annals of Plastic Surgery showing that using the Microvascular Anastomotic Coupler System, the company's mechanical device for connecting blood vessels without sutures, produces a reliable, strong arterial anastomosis in less time than a sutured connection in breast reconstruction procedures. The article encompassed the results of retrospectively reviewed microsurgical breast reconstructions performed between 1998 and 2004 by Christina Ahn, MD. Sixty patients, average age 45, underwent the procedure for a total of 80 flaps or tissue transfers. The coupler was used with 84% of the flaps. When a size discrepancy existed between flap and recipient vessels, the coupler selected reflected the smaller of the two diameters. The coupler was not used where the mismatch was significant or where the artery wall was exceptionally thick or calcified. The overall flap success rate was 100%.

• Varian Medical Systems (Palo Alto, California) said it will feature new advanced imaging and treatment technologies for image-guided noninvasive neurosurgery at the upcoming annual meeting of the American Association of Neurological Surgeons in San Francisco. Varian will be showcasing the Trilogy image-guided radio surgery instrument, which the company said delivers fast, comfortable, automated neurosurgery treatments. Varian's Trilogy radiosurgery solution incorporates a low-dose, high resolution X-ray imager that facilitates accurate patient positioning and makes it possible to rapidly deliver powerful, precisely placed beams to small areas in the brain and other parts of the body. Beam shaping can be accomplished using conventional radiosurgical cones with tiny apertures or with a dynamic multileaf collimator, a computerized mechanical device that uses many individually controlled tungsten leaves or fingers to sculpt the radiation beam and vary its intensity according to the neurosurgeon's treatment plan.

• Vidacare (San Antonio), manufacturer of the EZ-IO product system, a solution for immediate vascular access when conventional intravenous access is challenging or impossible, said it has received 510(k) clearance from the FDA to market the EZ-IO AD product system for use in humeral head access in patients with body weight greater than 39kg. Humeral head intraosseous capability provides for an EZ-IO insertion site above the diaphragm, a location preferred by many emergency physicians and trauma surgeons for rapid vascular access.