Ra Medical Systems, an excimer lasers and catheters developer, has secured clearance from the US Food and Drug Administration (FDA) to market its new laser radiation ablation (DABRA) system for the treatment of peripheral artery disease (PAD).
Designed as a less-expensive and safer solution, DABRA eliminates blockages from arteries in the limbs and is effective on all types of lesions.
In addition to altering the arteries, the new system can bypass the lesion and cross the chronic total occlusions (CTOs) with a wire.
Ra Medical Systems co-founder and chief executive officer Dean Irwin said: “DABRA’s US market clearance is the realisation 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, creating our company infrastructure and self-funding the development of DABRA.”
Expected to result in interventional procedures and better patient access, DABRA is said to require less procedural time, when compared to existing arterial blockage treatments.
The wireless system is considered to be safe as it remains in the patient’s true lumen and does not require subintimal access or perforation.
Its safety profile was confirmed in a clinical study, which demonstrated 95% positive outcome without clinically significant adverse events.