- Ra Medical Systems (NYSE:RMED -11.9%) reports progress with extending the shelf life of its DABRA catheter of six months or longer, featuring a braided overjacket to improve deliverability. It also said that it has completed all 116 items identified in a quality improvement plan that stemmed from an internal audit in late 2019.
- Though the Company is still implementing multiple remediations to address two primary issues related to the catheter’s limited shelf life as being the introduction of unwanted elements into its core water and the degradation of its inner coating. Engineering work for this catheter is expected to complete by mid-2021 and subsequently submit to the FDA for clearance.
- Dabra excimer laser system is currently in pivotal clinical trial to evaluate the safety and effectiveness as an atherectomy device for the treatment of peripheral arterial disease. Primary efficacy endpoint is the mean reduction in percent diameter stenosis in primary lesion following treatment with Dabra, before any adjunctive treatment.
- Dabra received FDA nod in May 2017 for use in ablating a channel in occlusive peripheral vascular disease.
- The company settled investigations into whether the company made false marketing claims when seeking FDA clearance for Dabra catheter for cardiovascular and skin conditions, earlier in month.