• Ascent Healthcare Solutions (Phoenix) said that the FDA has cleared two of its 510(k) submissions to reprocess specific Medtronic (Minneapolis) and Guidant (Indianapolis) cardiac stabilization and positioner devices. The Medtronic models include the Octopus evolution tissue stabilizer (as well as the other predecessor Octopus models), Starfish and Urchin Heart Positioners. Guidant models covered under this clearance include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems. The devices are mainly used in Off-Pump Coronary Artery Bypass (OPCAB) or “beating heart” procedures. About 350,000 U.S. patients undergo coronary bypass grafts annually. Currently, about 25% of the general population cases are being performed off-pump. Ascent Healthcare Solutions is an independent third-party reprocessor of single-use medical devices.

• Instrumentation Laboratory (Lexington, Massachusetts) reported receiving FDA clearance to expand the intended use for HemosIL D-Dimer HS to exclude venous thromboembolism (VTE) in outpatients suspected of deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability assessment model. HemosIL D-Dimer HS features expanded working range, high analytical sensitivity, virtually no interference from rheumatoid factor and minimal optical interference from hemoglobin, lipemia and bilirubin. It is automated on the ACL TOP system with time to results in less than five minutes. Instrumentation Laboratory makes in vitro diagnostic instruments.

• K2M (Leesburg, Virginia) reported the Phase II launch of its Pyrenees cervical plate system. Pyrenees’ low profile features a 1.5 mm leading edge which potentially minimizes patient discomfort, particularly esophageal irritation. In addition, this system has low profile drill guides, allowing for optimal viewing of the bone graft window. The “tifix” locking technology requires no additional locking mechanism, whereby each screw head forms an autogenic, or self-producing, lock to the plate. With screw flexibility of up to 45 conical degrees and a corresponding low torque driver, Pyrenees also combines the benefits of multidirectional screw placement with a rigid plate. K2M makes products for spinal pathologies and procedures.