• Cardica (Redwood City, California) reported that it has received clearance from the FDA to market its C-Port flex A anastomosis system in the U.S. The Flex A is a variation of Cardica's C-Port xA distal anastomosis system product line and further facilitates the automated anastomosis, or attachment of blood vessels and grafts, during less invasive coronary artery bypass graft (CABG) procedures. The C-Port flex A system has a flexible, rather than rigid, shaft; is effective in creating compliant anastomoses in vessels as small as one millimeter in internal diameter; and, can be used in either on- or off-pump CABG procedures. The flexible shaft allows surgeons to position the device to create a secure connection even in the most difficult to reach areas of the heart. Cardica makes automated anastomosis systems for CABG surgery.

• MedicalCV (Minneapolis) reported that Allen Raczkowski, MD, the director of robotic cardiac surgery at Banner Baywood Health Systems (Mesa, Arizona), performed a closed-chest, robotic, lone cardiac ablation procedure on an arrested heart using the Atrilaze surgical ablation system. The system is a laser-based technology platform to provide cardiac tissue ablation in both open and endoscopic surgeries. MedicalCV makes surgical ablation systems that utilize a laser energy technology platform to create precise lesions, or scars, on soft and cardiac tissue.

• MIV Therapeutics (Atlanta) reported the addition of a portfolio of new cardiovascular stents and related products, which have already been CE-marked for commercialization in several multibillion dollar markets, including Europe, Asia and India. The new products include the GenX CrCo thin-strut coronary stent system, which was recently combined with MIVT's biocompatible stent coatings in a milestone bench test showing that together, the technologies pass critical FDA fatigue test guidelines. Other products acquired by MIVT include the GenX stainless steel coronary stent system, the X-ACT Inflation Device, a haemostatic y-connector adaptor kit, an insertion tool, a guide wire torquer and a high-pressure 3-way stopcock. Some credit for this new portfolio of products can be traced to MIVT's purchase of cardiovascular device company Biosync Scientific this February (Medical Device Daily, Feb. 21, 2007). MIVT makes biocompatible coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices.

• Polymedco (Cortlandt Manor, New York) reported the introduction of the BTA stat test — a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine. The specificity of the BTA stat test was 93-95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study. The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses. Requiring five drops of urine, the result is delivered in five minutes. The appearance of a line in the patient window indicates a positive result. Polymedco describes itself as one of the leading marketing and distribution companies in the clinical laboratory marketplace.

• Possis Medical (Minneapolis) reported that its AngioJet Spiroflex VG rapid exchange catheter has been approved by FDA for blood clot (thrombus) removal in coronary conduits. The catheter was first introduced to remove thrombus in larger peripheral arteries, and the recent approval allows the catheter to be used in saphenous vein bypass grafts in the heart and larger native coronary vessels. The catheter offers performance benefits, including: increased trackability inside the vessel; improved crossing in difficult anatomy; and 360-degree thrombus removal. Possis makes products for endovascular procedures.

• PuriCore (Malvern, Pennsylvania) said that it has received FDA clearance allowing it to market its proprietary Sterilox endoscopy high-level disinfectant system as a medical device in the U.S. The Sterilox system produces a high-level disinfectant solution that is indicated for use in reprocessing and disinfecting heat-sensitive medical instruments, including endoscopes, between patient procedures. Sterilox solutions are completely non-toxic and are of no risk to patients, healthcare professionals, or the environment. Puricore focuses on antimicrobial technology.

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