• Candela (Wayland, Massachusetts) reported receiving FDA clearance for its family of pulsed dye lasers for the treatment of benign epidermal pigmented lesions. The clearance adds to the previously cleared indications for treatment of facial veins, rosacea, leg veins, port wine stains, scars, wrinkles, psoriasis, stretch marks and warts. Candela bills itself as a pioneer of the aesthetic laser market and says that it has an installed base of 8,000 lasers worldwide.

• Conceptus (San Carlos, California), developer of the non-incisional birth control procedure Essure, said it submitted a pre-market approval supplement (PMA-S) to the FDA to extend effectiveness data on the Essure labeling. The supplemental filing supports an extension of the effectiveness of Essure to four and five years of follow-up and is expected to be unchanged from the 99.8% effectiveness rate for one, two and three years of follow-up. There continue to be no pregnancies to date among patients who had been enrolled in the Essure Phase II and pivotal trials, according to Conceptus. The Essure procedure deploys a micro-insert into the fallopian tube through the cervix, using a minimally invasive transcervical tubal catheter. The device is designed to elicit tissue growth in and around the micro-insert to form an occlusion in the fallopian tube.

• Cordis (Miami Lakes, Florida) said clinical data regarding the use of its Cypher sirolimus-eluting coronary stent in difficult-to-treat coronary lesions will be presented at next week's American College of Cardiology scientific sessions in Orlando, Florida. Four late-breaking presentations on March 6 will examine the stent's clinical performance across a variety of patient populations. Among the presentations at the conference will be results from the REALITY trial, a randomized prospective global study that examines the Cypher stent vs. the Taxus stent from Boston Scientific (Natick, Massachusetts); the ARTS-II trial, which details long-term results of a multi-center prospective, non-randomized study of multi-vessel stenting; the SIRTAX trial, an independent randomized comparison of the Cypher and Taxus stents; and the ISAR-DIABETES trial, a German study designed testing the safety and efficacy of the Cypher and Taxus stents in the treatment of patients with diabetes.

• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) said interim results of the clinical study of its BrainGate Neural Interface System were presented at the annual meeting of the Association of Academic Physiatrists in Tucson, Arizona. The BrainGate System is the subject of a pilot study under an FDA investigational device exemption. The goal of the BrainGate development program is to create a universal operating system that will allow physically disabled people to quickly control a range of devices such as computers, assistive technologies and medical devices, using their thoughts. The poster presentation of these interim results from the feasibility study were made by Jon Mukand, MD, PhD, an investigator for the BrainGate System study at the Sargent Rehabilitation Center and a faculty member of the Brown University School of Medicine (both Providence, Rhode Island). According to Mukand, "The first patient in the BrainGate pilot trial has now passed six months from initial implantation and there have been no adverse events. The BrainGate System continues to function as planned, allowing the patient to demonstrate that he can control a computer, external appliances, and a prosthetic limb. We are extremely encouraged by what has been achieved to date, and are increasingly convinced that, with additional development, the BrainGate System may represent a significant breakthrough in improving functional capability and quality of life for people with severe neurological disabilities."

• Envisioneering Medical Technologies (St. Louis) said the FDA approved its TargetScan device for prostate biopsies and for improving the accuracy of less-invasive cancer treatments. The company said TargetScan is the latest innovation in prostate mapping, biopsy and cancer treatment guidance. Combining 3-D image with a stationary probe, the technology aids in planning and executing targeted prostate biopsies – potentially improving treatment outcomes with less-invasive procedures. The device is available in "select" urology clinics across the country for field testing, Envisioneering said. The company said it plans a broad TargetScan launch in May in conjunction with the American Urology Association annual conference in San Antonio.

• Gyrx (Jacksonville, Florida) and Endox, its wholly owned endoscopic subsidiary, reported the U.S. release of its Visu-Loc 5 mm endoscopic clip applier. Visu-Loc is used in general surgery to ligate the cystic duct during laparoscopic cholestectomy procedures. While also used in gynecologic and urological procedures, the clip's technology allows its ligation force to remain constant, especially on shrinking tissue. Gyrx said the Visu-Loc titanium clip is a breakthrough in clip technology. The clip is pre-formed in a closed state, allowing the legs to be under tension or pre-load. The clip's ligation force is developed by the coil in the rear of the clip, allowing it to be placed onto tissue without being dependent on the applier's jaw force. The clip is delivered through a 5 mm trocar port and offers a 13% longer clip compared to clips from 10 mm devices.

• Hypoguard USA (Edina, Minnesota), a provider of institutional glucose monitoring, introduced NewTek, terming it the world's most convenient blood glucose monitoring system for diabetes. This disposable system, much like disposable cameras with pre-loaded film, comes with 100 test strips inside the meter and can be tossed away when finished. Available only at Wal-Mart pharmacies, the NewTek Blood Glucose Monitoring System offers a fast read time, requires a small blood sample and warns users when test strips have passed their expiration date, which is six months after opening the meter. It saves all 100 tests in memory, providing an average of the last 10 readings.