Regulatory and Intellectual Property

The DABRA Laser System is supported by 3 FDA 510(k) clearances, including associated clinical studies, technical documentation, and regulatory files acquired by IEVC under the DABRA asset acquisition from Catheter Precision.

The laser console platform has undergone testing to recognized IEC and electromagnetic compatibility standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22. IEVC continues to advance additional quality system and manufacturing initiatives.

The DABRA acquisition included 8 issued patents, trademarks, engineering documentation, manufacturing records, Device Master Records (DMR), clinical data, and related technical files supporting the platform.

IEVC believes these assets provide a strong foundation for the continued advancement and commercialization of DABRA technology.

IEVC is led by a team with decades of experience in excimer laser systems, vascular intervention, FDA regulatory strategy, quality systems, and medical device commercialization.

Collaboration with experienced DABRA operators is at the heart of our approach. By understanding the needs of interventionalists and patients, we continue to refine our laser and catheter technologies, ensuring our innovations are both effective and user-friendly in real-world endovascular interventions.