• CryoCath (Montreal), a developer of cryotherapy products to treat cardiovascular disease, reported six-month follow up data from 18 patients treated during the feasibility stage of its STOP AF [atrial fibrillation] IDE trial. The trial, now in the pivotal stage, is assessing the company's Arctic Front catheter to treat atrial fibrillation (AFIB). This bi-directional, double-balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Of the 33 patients treated during the feasibility stage, the second cohort of 18 patients, which have been treated with 23 mm or 28 mm catheters as in the pivotal trial, has now reached the 6-month mark. All patients from the second cohort were free of detectable AFIB at six months. Three of the patients required a second procedure, which is permissible under the protocol set for the trial. Of these three patients, one is still receiving anti-arrhythmic drug (AAD) treatment. All of the remaining 17 patients are off AAD's. In comparison to the original 15 patients in the first cohort of which 73% were AFIB free at the six-month mark, the results show "noteworthy improvement," the company said.

• Medtronic Spinal and Biologics (Memphis, Tennessee) reported that it received FDA approval to begin marketing INFUSE Bone Graft for certain oral maxillofacial and dental regenerative bone grafting procedures. INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and tibial fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body's own biology to induce normal bone formation. That is the third PMA since 2002 for the INFUSE Bone Graft technology, the company said.

• Molnlycke Health Care US (Norcross, Georgia) reported the introduction of BioExam, a powder- free, non-latex, sterile examination glove, featuring a polymer inner coating for ease of donning, removing the need for a powder lubricant. This eliminates the risk of powder-related complications and reduces the risk of allergic reactions to aerosolized natural rubber latex proteins, the company said. The glove is packaged like surgical gloves, in a peel pouch for easy donning to maintain sterility. It is available in singles or pairs. Molnlycke Health Care US focuses on prevention of surgically-related infections for both patients and healthcare workers, and makes powder-free surgical gloves.

NDS Surgical Imaging (San Jose, California) reported its expansion into surgery-related infection control markets at the 54th annual congress of the Association of Peri-Operative Registered Nurses (AORN) in Orlando, Florida. The new business expansion addresses infection control needs by introducing next-generation hospital grade disinfectants and barrier protection solutions. NDS Surgical Imaging is focused primarily on reducing the incidence and costs of surgical-site infections (SSI) at the point-of-care. OR-Cleanse and Steri-Wipe are disinfectants designed for hard, non-porous surfaces of surgical and imaging equipment. Sterile-Touch screens provide effective barrier protection against microbial transmission derived from medical imaging equipment at the point-of-care. They are designed specifically for visualization devices that require constant contact with clinicians.

• Oculus Innovative Sciences (Petaluma, California) reported publication of results from a non-randomized study of its Dermacyn Wound Care (DWC) product, conducted in Italy for the treatment of wide post-surgical infected diabetic foot ulcers. The results were published in the current issue of International Journal of Lower Extremity Wounds. Researchers at the University of Pisa (Pisa, Italy) used an experimental study design comparing 33 patients with diabetes who had post surgical lesions > 5 square centimeters without ischemia. The study indicated that patients treated with Dermacyn in combination with antibiotics had a significant decrease in healing time and duration of antibiotic therapy, and experienced a higher healing rate at six months compared with the group treated with diluted povidone iodine in combination with antibiotics.

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