International

Destruction of Arteriosclerotic Blockages by laser Radiation Ablation

DABRA is our minimally-invasive excimer laser and disposable catheter system that is used by physicians as a tool in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease, a form of peripheral artery disease (PAD), both above- and below-the-knee. DABRA reduces all plaque types into their fundamental chemistry, such as proteins, lipids, and other chemical compounds, eliminating blockages by essentially dissolving them.

DABRA is a novel technology. We believe that our liquid-filled, full-aperture ratio catheter is designed to deliver an endovascular treatment for vascular blockages and offers benefits over competing treatments and therapies.

DABRA is easy to use and can cross and remove a broad range of blockage types without the use of a guidewire.

DABRA employs photoablation, or the removal of body tissue by using photons, to remove blockages by breaking the bonds of the obstructing plaque directly. Unlike many treatments for PAD that may damage the arterial wall, DABRA quickly dissolves plaque with minimal vascular trauma. DABRA is minimally invasive and its non-mechanical mechanism of action is designed to not stretch the arterial walls or penetrate the layers of arterial tissue known as the subintimal space.

DABRA Catheter

DABRA is a full aperture ratio, forward ablation catheter, delivering fast ablation of all types of plaque, without the “dead-space” of fiber optic bundle catheters. It produces a clear, concentric lumen while minimizing trauma to the vasculature. The DABRA catheter has a 1.5 millimeter blunt-tip design and a working length of 150 cm. DABRA removes plaque by photoablation, limiting the vascular trauma which may be caused by the mechanical mechanism of action used in competing products.

In May 2017, we received FDA 510(k) clearance to market the DABRA laser system and disposable DABRA catheter in the U.S. for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

Pivotal Study Demonstrates 94% Effectiveness

The safety and effectiveness of the DABRA laser system and disposable DABRA catheter is supported by our pivotal study, a non-randomized, prospective, multi-site study conducted to evaluate lesion crossing by way of plaque photoablation using DABRA in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease. The study enrolled 64 subjects at four sites with both above-the-knee and below-the-knee lesions. 50 subjects were included in the FDA’s data used to determine the 510(k) clearance. The final study results demonstrated 94% effectiveness with 0% reported device-related SAEs, both related to the 50 subjects included in the data submitted to the FDA and the 64 subjects enrolled in the study.