Ra Medical receives FDA IDE approval for atherectomy study

The FDA has approved Ra Medical Systems (NYSE:RMED) to initiate an investigational device exemption (IDE) to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.

The trial will enroll up to 100 patients with symptoms of peripheral vascular disease (PAD) (Rutherford Class 2-4).

The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment.

https://seekingalpha.com/news/3532969-ra-medical-receives-fda-ide-approval-for-atherectomy-study