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 the removal of 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 photochemical ablation, 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, photochemically 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.
The DABRA catheter is a full aperture ratio forward cutter, 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 photochemical ablation, 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 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.
|Used With||Introducer, Sheath, or Guide Catheter|
|Working Length||150 cm|
|Sheath Compatibility||5 Fr, 6 Fr, 7 F|
|Tip Diameter||5 Fr (.061″ / 1.5 mm)|
|Shaft Diameter||5 Fr (.061″ / 1.5 mm)|
|Minimum Vessel Diameter||2.0 mm|
|Firing Device||Foot Pedal|
|Size||14”W x 27”L x 32”H (36cm x 68cm x 82cm)|
|Electrical Inputs||120 VAC, 6 A, 47 Hz to 63 Hz / 230 VAC, 3 A, 47 Hz to 63 Hz|
- Safety. DABRA is designed to track the patient’s true lumen, or the center of the artery, and not to penetrate between the layers of the arterial structure known as the subintimal space. No serious device-related adverse events were reported in our 2017 pivotal study.
- Efficacy. Unlike many treatments for PAD that do not remove plaque, DABRA employs photochemical ablation to disintegrate plaque by breaking its chemical bonds, thereby reducing the plaque to the components of its fundamental chemistry.
- Utility. DABRA enables physicians to remove plaque from long and calcified lesions in arteries located in the lower extremities both above- and below-the-knee. DABRA is able to cross a wide variety of plaque, removing vascular blockages that other products are unable to cross.