OxyTote Recall Labeled Class I
After reports of serious user injuries and one death, the FDA has determined that a recall of a portable oxygen system regulator from Western Enterprises should be Class I. The company was alerted to the possibility of that the product’s compressed gas oxygen cylinder could ignite and explode, and followed up with a recall notice in January saying three events had been received, including the death. In a follow-up letter, the company said that all OxyTOTE, oxyQuik and AirTOTE products are subject to the recall except units marked with a hard stamped “T” on the oxygen cylinder and the brass portion of the regulator body.
Philips, Profound Medical to Collaborate
Royal Philips has signed a joint development agreement to integrate Profound Medical’s proprietary transurethral ultrasound ablation technology designed to treat prostate cancer with the Ingenia and Achieva 3T MRI systems. Profound’s TULSA technology allows for a single-session procedure and is associated with lower rates of side effects, according to Philips. Profound is expected to release 12-month data from its 30-patient safety and feasibility study, with the goal of obtaining a CE mark and commercialization of TULSA-PRO in Europe and Canada next year.
Stryker to Buy Turkish Bed Maker
Stryker has inked a definitive agreement to acquire Muka Metal in an all-cash transaction. The Turkish company sells hospital beds, stretchers and patient room furniture and accessories. The two firms have had a distribution agreement for Latin America since 2012. The transaction is expected to close in the third quarter. Stryker did not disclose the value of the deal.
Boston Scientific Starts Scaffold Study
Investigators have begun the evaluation of Boston Scientific’s first fully resorbable drug-eluting scaffold system in patients with atherosclerotic coronary lesions. The study, which will enroll up to 30 patients, has started accepting subjects at a Melbourne, Australia, facility. The resorbable polymer scaffold incorporates elements from the company’s Synergy stent system, including a resorbable polymer and an ultrathin everolimus coating.
St. Jude Medical’s Penta Lead Wins FDA Nod
The FDA has approved MR-conditional labeling for St. Jude Medical’s Penta 5-column paddle lead for spinal cord stimulation therapy to manage chronic pain. The lead will be available for use with the company’s Protégé MRI system in the U.S. The product will become the first marketed five-column paddle lead on the market, allowing patients to safely undergo head and extremity MRI scans, according to St. Jude.
Micell to Study MiStent
Micell Technologies has started enrolling patients in its clinical trial evaluating the MiStent SES sirolimus-eluting stent system for coronary artery disease. The study, which is comparing the device against Essen Technologies’ Tivoli stent system, has a primary endpoint of nine-month in-stent late lumen loss. The Durham, N.C., company expects to enroll about 428 patients across 18 clinical sites in China.