• ThermoGenesis (Rancho Cordova, California) said that the FDA has granted clearance for the company to market the CryoSeal FS autologous fibrin sealant, as an adjunct to hemostasis in liver resection surgery. The CryoSeal FS, an automated device and companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. The system produces a second-generation surgical sealant which harvests from a patient's plasma the two interactive protein component solutions of a fibrin sealant: (1) the wound healing proteins of fibrinogen, fibronectin, Factor VIII, von Willebrands Factor and Factor XIII and (2) the activating enzyme thrombin. When combined at the bleeding wound site, the two components form an adhesive gel that assists in stopping the bleeding and bonds tissue. ThermoGenesis makes product platforms that enable the processing and cryopreservation of stem cells for regenerative medicine and processing of protein gels for surgical wound care.

• Cook Urology (Spencer, Indiana), a division of Cook Medical, reported the availability of its Resonance Metallic Ureteral Stent in the U.S. The device has the ability to improve the quality of life for patients during cancer treatment by relieving ureteral blockage, a painful and often debilitating side-effect. The stent is also indicated for most other causes of extrinsic ureteral compression. The development of the ureteral stent was motivated by the rise in gender-specific cancers; which has led to a more aggressive approach for treatment. This in turn has led to an increased need for ureteral drainage during chemotherapy-based cancer treatments. The stent's design allows the patient's urinary system to drain normally while eliminating the need for a costly nephrostomy tube that can interfere with the patient's quality of life. Cook Medical and its divisions make interventional devices.

• Cook Medical (Bloomington, Indiana) has received FDA clearance for a permanent indication for its newest vena cava filter, the Celect. The Celect is an implanted expandable metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. The Celect uses a conical shape with a unique strut design that improves centering in the vessel and reduces in-growth except at the desired end points. Cook Medical integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes.

• Sanofi-aventis (Bridgewater, New Jersey) reported that Lantus SoloSTAR, a disposable insulin pen, is now available. The SoloSTAR pen offers people with diabetes a more convenient option for taking their insulin than through traditional methods. The pen is prefilled with Lantus (insulin glargine [rDNA origin] injection), the only 24-hour insulin approved exclusively for use once a day, for the treatment of hyperglycemia in people with Type 1 or Type 2 diabetes. SoloSTAR is the only prefilled disposable insulin pen that allows patients to administer doses from 1 up to 80 units, in one injection. With Lantus, the insulin is released into the bloodstream at a relatively constant rate throughout the day and night; therefore it has no pronounced peak. Sanofi-adventis specializes in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines.