LDR (Austin, Texas) is moving forward in its bid to gain approval for the commercial sale of its Mobi-C cervical artificial disc in the U.S. The firm recently reported the submission of its two level Mobi-C cervical artificial disc PMA to the FDA and said that it is one of only two companies to have completed a two-level randomized IDE trial with two-year follow up. (Medical Device Daily)
Covidien (Dublin, Ireland) will forego gathering additional clinical data for its Solitaire FR revascularization device and seek FDA approval. The move comes after the data safety monitoring board (DSMB) reviewed data from the SWIFT (Solitaire FR With Intention For Thrombectomy) trial and recommended that Covidien stop enrolling patients and submit the trial data to the FDA for approval. (Medical Device Daily)
Sanuwave (Alpharetta, Georgia) reported the publication of research conducted in Taiwan comparing the effectiveness of the company's dermaPACE device with hyperbaric oxygen therapy (HBOT) in treating chronic diabetic foot ulcers. (Medical Device Daily)
Making headway in an attempt to bring the CorPath 200 System to market, Corindus Vascular Robotics (Natick, Massachusetts) reported that the clinical trial of the system has begun. The first PCI procedures using the system were performed at New York-Presbyterian Hospital/Columbia University Medical Center (New York) and St. Elizabeth's Medical Center (Boston) in the Percutaneous Robotic-Enhanced Coronary Intervention (PRECISE) study. (Medical Device Daily)
A new drug-device combination, which is a non-surgical, tissue-preserving therapeutic procedure to more effectively remove HPV infection and treat precursors of cervical cancer, has been accepted for use in a phase II clinical trial by the FDA. Cevira, which is being developed by Photocure (Oslo, Norway), with the help of Sagentia (Cambridge, UK), is slated to be evaluated in clinical trials with sites throughout the U.S. and Europe during the spring of 2011, both companies report. (Medical Device Daily)