Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy system. The Conshohocken, Pa.-based company’s Revolution device is indicated for atherectomy of the peripheral vasculature and is designed to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. In the 121-person Reveal IDE […]
FDA clears Rex Medical’s thrombectomy system
Rex Medical won FDA clearance for its Cleaner15 Rotational Thrombectomy System, a device designed to clear occluded blood vessels and stents.
The Conshohocken, PA.-based medical device company inked a deal with Argon Medical Devices for marketing and distributing its Cleaner and Cleaner15 technologies in the U.S., the European Union, Latin America, Canada and select Asia-Pacific geographies, according to a press release.
Study: Cordis Corp.’s TrapEase vena cava filter shows high fracture rate
TrapEase permanent vena cava filter
A new study reported a high fracture rate among permanent inferior vena cava filters made by Cordis Corp., a device-making arm of Johnson & Johnson (NYSE:JNJ).
In a Japanese study of 20 patients with Cordis’ TrapEase IVC filter, the devices fractured in half the patients at 50 months.
Rex Medical kills Angiotech deal, alleging breach of contract
Angiotech Pharmaceuticals Inc. (OTC:ANPI) received a termination notice for the licensing agreement it has with Rex Medical LP for its Option retrievable vena cava filter.
Conshohocken, Pa.-based Rex Medical alleges that Angiotech "materially breached its obligations" under the deal, according to Angiotech.
FDA cautions doctors on fracture risks with IVC filters
The Food & Drug Administration is recommending that physicians consider removing retrievable inferior vena cava filters after logging 921 reports of "adverse events" related to the devices.
The federal watchdog agency warned that certain IVC filters could fracture, causing pieces of the device to travel through the bloodstream to other parts of the body.
