• Angiotech Pharmaceuticals (Vancouver, British Columbia) reported the U.S. launch of its Quill Self-Retaining System (SRS) for tissue approximation. Using a barbed design, Angiotech said it believes that the Quill SRS offers an elegant timesaving option for surgeons, which eliminates the need for knots while providing improved tissue approximation. In addition to other benefits, Angiotech believes that the Quill SRS could reduce procedure times, resulting in cost-savings in the OR and shorter operation times for patients. The Quill SRS could be of even greater benefit to the surgeon or physician whenever knots can be challenging to tie, such as in endoscopic procedures. Angiotech produces wound closure products for tissue approximation and ligation.

• Cytori Therapeutics (San Diego) received U.S. 510(K) clearance from the FDA’s Center for Devices and Radiological Health (CDRH) for its adipose tissue processing system with related Celase tissue processing reagent. This system with the Celase reagent is intended for use in plastic and reconstructive, thoracic, gastrointestinal, urological orthopedic, and other surgeries when processing fat or soft tissue is desired. The specific claims for the adipose processing system, Cytori’s Lipoplasty System with Celase Reagent, are as follows: The Cytori adipose processing system is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue is required and intended for use within Cytori’s adipose tissue processing system. Cytori Therapeutics is developing and seeks to commercialize stem and regenerative cell therapies for cardiovascular disease, reconstructive surgery, and many other serious chronic and life-threatening conditions

• EMedicalFiles (Atlanta), a web-based health information technology (HIT) company, introduced its new electronic healthcare record (EHR) system. The eMedicalFile’s Patient-Centric EHR is a web-based EHR providing critical patient information to providers when and where they need it. The patient grants continuing access to their primary care physician and access to others as required. Medical information is available on demand to the patient and those he or she designates for care. Since it is web-based, the eMedicalFiles EHR requires only an internet connection, a computer, and patient authorization. The system is scalable and adaptable to new technology as it comes online. eMedicalFiles is a health information technology company that provides products that serve physicians, hospitals, Federal, State and third-party payers, and all patients including Medicaid and Medicare.

• FlowCardia (Sunnyvale, California) reported on the availability of the Crosser 14P, Crosser 14S and Crosser 18 chronic total occlusion (CTO) recanalization catheters in the European Union. The catheters are delivered using standard guidewires to the site of the occlusion in the legs. They then utilize high-frequency vibration to facilitate guidewire crossing of the occlusion allowing for subsequent plaque debulking (removal), balloon angioplasty or stent placement. For many patients, this cath-lab-based, minimally invasive approach to CTO recanalization can eliminate the need for traumatic bypass graft surgery or leg amputation. FlowCardia produces endovascular devices for coronary and peripheral CTO recanalization,

• Transgenomic (Omaha, Nebraska) reported that its Transgenomic Laboratories division has added 10 nuclear gene screening assays. The 10 autosomal genes encode key proteins for mitochondrial maintenance and function including: POLG1, DGUOK, TP, TK2, SURF1, SCO1, SCO2, COX10, BCS1L, and SLC25A4. It has been established that mutations in these genes are associated with various clinical disease syndromes that involve mitochondrial dysfunction. Early identification of these mutations can facilitate accurate diagnosis and improve patient care. Transgenomic is a biotechnology company that provides systems, products, discovery and laboratory testing services to the academic and medical research, clinical and pharmaceutical markets for automated high sensitivity genetic variation and mutation analysis in the fields of pharmacogenomics and personalized medicine.

• Visiogen (Irvine, California) said it has received FDA approval to expand its Phase III U.S. clinical trial for its Synchrony dual optic accommodating intraocular lens. Already approved for use throughout the European Union, the Synchrony system is being studied in a multi-center trial in the U.S. to evaluate safety and effectiveness and the potential for near and intermediate vision. The Synchrony system, intended for use in cataract and refractive patients, incorporates a dual optic lens with a pre-loaded injector. The entire system is self-contained and ready for use without the need for lens handling. The dual optic lens can be inserted through a 3.6 mm – 3.8 mm clear-corneal incision. The single-piece silicone lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5 mm high-power anterior optic and a 6 mm negative power posterior optic; the spring action moves the front optic and changes the eye’s focus from near to far. This unique combination of positive- and negative-powered optics is customized for each patient. To date, the Synchrony lens has been implanted in over 400 patients worldwide.

• Zoll Medical (Chelmsford, Massachusetts) reported that it received clearance from the FDA to market the Zoll E Series with Real CPR Help technology. Zoll’s Real CPR Help allows rescuers to instantly see and hear how well they are performing the rate and depth of CPR chest compressions, the company said. With this clearance, the E Series becomes Zoll’s first advanced pre-hospital device to provide this instantaneous feedback. Zoll Medical develops technologies designed to help advance the practice of resuscitation.