Medical excimer laser developer Ra Medical said it won FDA 510(k) clearance for its Dabra system designed to treat patients with peripheral artery disease.
The Carlsbad, Calif.-based company said that the system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, touting the device and associated procedures as cost and time saving.
“Dabra’s pivotal study demonstrated 95% success without any clinically significant adverse events. Furthermore, the Dabra Catheter is unique in its ability to cross Chronic Total Occlusions without having to cross the lesion with a wire, and it also debulks and modifies arterial blockages, making it an invaluable clinical tool,” Dr. Ehtisham Mahmud of the UC San Diego School of Medicine
“Dabra is what we have been waiting for to better treat our patients. It is a two-in-one. You cross the blockage and remove the plaque from the artery. It is safe, because it stays in the patient’s true lumen and does not go subintimal or perforate – common complications of other devices – and it’s effective on all types of lesions. It is revolutionary wireless technology and effective in cases in which other devices have failed. Dabra should be part of every cardiovascular catheter lab’s armentarium,” Dr. Athar Ansari of the California Heart & Vascular Clinic said in a prepared statement.
“Dabra’s U.S. market clearance is the realization of more than a decade of dedication to the pursuit of delivering a more effective, safer and less expensive way to remove blockages from arteries to save limbs and, ultimately, save lives. To do so, we built Ra Medical Systems and pioneered our cost-effective, small and portable Pharos Excimer Laser for dermatological diseases, thereby creating our company infrastructure and self-funding the development of Dabra. We built our company in a way that no other cardiovascular company has been created, and we will continue delivering groundbreaking catheters, lasers and other devices to treat unmet medical needs in cardiovascular, dermatology and other therapeutic areas of medicine,” co-founder & CEO Dean Irwin said in a press release.
Last October, Ra Medical said it won CE Mark approval in the European Union for both its Dabra artherectomy catheter system and its Pharos excimer laser designed to treat skin diseases.