Return to site

FDA Clears Ra Medical System's DABRA Arteriosclerosis Laser

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.

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.


READ MORE: http://www.massdevice.com/fda-clears-ra-medicals-dabra-areteriosclerosis-laser/

All Posts
×

Almost done…

We just sent you an email. Please click the link in the email to confirm your subscription!

OKSubscriptions powered by Strikingly