TGA Finishes Morcellator Review
Australia’s Therapeutic Goods Administration has updated the instructions for use on all laparoscopic morcellators approved for use in the country to ensure doctors and patients understand the potential risks. Specifically, the IFU warns that morcellators should not be used in patients with suspected uterine tumors and specifies that physicians be credentialed and trained on the devices. The TGA undertook a review of laporascopic morcellators in April 2014 after U.S. regulators warned that morcellation during certain uterine surgeries could spread cancer cells into surrounding tissue. In safety advisories issued last year, the TGA put the risk to Australian women undergoing morcellation at about one in 1,000.
Cook Undergoes IMDRF Single Audit
Cook Medical’s Limerick, Ireland, plant has signed on with the International Medical Device Regulators Forum’s single audit program, making it the first Irish facility to do so and one of just six companies worldwide to have MDSAP audits since the program launched last summer. The site underwent a two-day initial certification audit in April. MDSAP is based on a three-year audit cycle, with initial audits followed by partial surveillance audits each of the next two years and a complete recertification audit at the end of three years. Regulators participating in the MDSAP pilot include the FDA, Health Canada, Australia’s Therapeutics Goods Administration, Brazil’s Anvisa and Japan’s Pharmaceuticals and Medical Devices Agency.
Silk Road’s Stent System Approved
Silk Road Medical’s Enroute transcarotid stent system has secured FDA approval, making it the first of its kind to be implanted in the carotid artery using a direct common carotid access point. The stent is indicated for high surgical risk patients and intended for use alongside the Enroute transcarotid neuroprotection system, which won FDA 510(k) clearance in February. The neuroprotection system provides access to the common carotid artery to reverse high rates of temporary blood flow, protecting the brain from stroke.
Guided Therapeutics’ PMA Rejected
The FDA has rejected a July 2014 amendment to Guided Therapeutics’ PMA for the LuViva advanced cervical scan, saying it needs to see more patient data before signing off. LuViva, Guided’s first product, is a noninvasive device that uses spectroscopy to measure light interaction with tissue to identify chemical and structural markers for cervical cancer. The device is available in Europe.
Sunshine Heart Resumes Trial Enrollment
Sunshine Heart said Tuesday it has resumed patient enrollment in a clinical trial of its C-Pulse heart assist system, following FDA approval. The devicemaker paused enrollment March 6 after four patients died. However, an independent committee ruled the deaths weren’t device-related. The multicenter trial will test the system’s safety and efficacy in the treatment of NYHA Class III and ambulatory Class IV heart failure. Sunshine plans to enroll patients across 40 clinical sites. The device, which is investigational status in the U.S. and Canada, received CE Mark approval in 2012.