Ra Medical Systems Archives - Medical Design Sourcing

Ra Medical says demand is rising for its non-invasive electrophysiology mapping system

Ra Medical Systems (NYSE:RMED) today announced an increase in clinical adoption for its VIVO system across hospitals.

The product line falls within Ra Medical’s electrophysiology division, called Catheter Precision. Catheter Precision recently expanded its sales and clinical support team in the U.S. as part of a full product launch for VIVO. Earlier this month, Ra Medical also began to expand its distribution channels outside the U.S.

VIVO (view into ventricular onset) is a 3D, non-invasive mapping system. It enables physicians to identify the origin of ventricular arrhythmias pre-procedure. This streamlines workflows and reduces procedure time. Ra Medical’s Catheter Precision division received both FDA clearance and CE mark approval for VIVO.

Patricia Kennedy, chief commercial officer at Catheter Precision, said VIVO remains under review with “several notable accounts.” Kennedy added that hospitals increasingly leverage technolog…

Ra Medical announces international distribution expansion

Ra Medical Systems (NYSE:RMED) announced the undertaking of a new effort to expand its distribution outside the U.S.

Last week, the company filed for CE mark approval for its LockeT device that assists in percutaneous puncture site closure. RA Medical says its expansion effort reflects its expectation of receiving CE mark during the third quarter.

The company recently entered into a distribution agreement with Medilynq to distribute its products in some Middle East countries. That agreement includes distribution in Saudi Arabia, Jordon, Oman, UAE, Qatar, and Kuwait. In conjunction with this agreement, Medilynq already placed its first order for a VIVO system from Ra Medical. The company also said it has engaged with Bioline, a new distributor in Spain.

Ra Medical said it identified a number of international distributors with interest in its products. It also engaged the expertise of a consulting marketing company to help identify and manage distributors …

Ra Medical realigns board of directors following merger

Ra Medical Systems (NYSE:RMED) this week announced the realignment of its board of directors in conjunction with the recently announced merger with Catheter Precision.

David Jenkins joins the board as executive chair, and James Caruso will serve as a director. Martin Colombatto, Will McGuire and Susann Meline will serve as directors. Additionally, directors Joan Stafslien and Richard Mejia have resigned.

Get the full story on our sister site, Medical Tubing + Extrusion.

Ra Medical appoints interim CFO

Ra Medical Systems (NYSE:RMED) announced today that it appointed Brian D. Conn as its interim chief financial officer (CFO).

Conn will serve as the company’s principal financial officer and principal accounting officer, effective immediately.

He has served as a consultant to the Carlsbad, California-based developer of the Dabra excimer laser system for treating vascular diseases since May 25, 2022. According to a news release, Conn replaces Will McGuire, who assumed the interim CFO role on July 8, following Andrew Jackson’s departure from the role.

McGuire will continue in his positions as CEO and director of the company, Ra Medical said.

“We are fortunate to have a professional with Brian’s extensive and highly relevant experience step into our senior financial position as our board of directors continues to assess strategic alternatives with the goal of maximizing value for Ra Medical’s stockholders,” McGuire said in the release.

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Ra Medical enrolls 100th patient in clinical study of Dabra laser system

Ra Medical Systems (NYSE:RMED) announced today that it enrolled 100 subjects in a pivotal trial for its Dabra excimer laser system.

Carlsbad, California-based Ra Medical’s pivotal trial will evaluate the safety and effectiveness of Dabra as an atherectomy device for treating peripheral arterial disease (PAD).

The study aims to enroll up to 125 subjects. According to a news release, the “unpredictable nature” of the COVID-19 pandemic means the company can’t accurately predict when enrollment will be completed, but the aim is for the third quarter of 2022 with six-month follow-up to be completed in early 2023, should the study fall in line with expectations.

Ra Medical’s study will enroll subjects with PAD symptoms at up to 10 sites, with outcome measures including safety, acute technical success and clinical success.

The primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s prim…

Ra Medical Systems wins patent for laser ablation support catheter

Ra Medical Systems today said it received a patent from the U.S. Patent and Trademark Office for a support catheter used with a small flexible liquid core catheter for laser ablation.

The Carlsbad, California-based company was granted its 10th patent for the support catheter that is to be used in conjunction with the Dabra liquid core ablation catheter. Ra Medical designed it for use in laser ablation of arterial plaque blockages to restore blood flow.

Get the full story on our sister site, Medical Tubing + Extrusion.