Special to MD Monthly

San Antonio-based Heart Endovascular & Rhythm of Texas recently began performing a groundbreaking procedure with its new DABRA System to treat patients with Peripheral Artery Disease (PAD) and prevent them from undergoing diabetic amputations.

According to the City of San Antonio Metropolitan Health District, 14.2 percent of Bexar County adults have been diagnosed with (type 1 or type 2) diabetes, which is higher than the state and national average. People with diabetes are often at risk of amputations.  

The Heart Endovascular & Rhythm of Texas is the first outpatient facility in Texas to commercially work with Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, to cross and treat arterial blockages via femoral artery access. It is also the first in the country to perform a procedure independent of the clinical trials for FDA clearance. This follows the California Heart & Vascular Clinic in El Centro, Calif., which participated in a FDA clinical study and treated the first post-FDA clearance patient, associated with the study, in June.

“There are very few devices that are available today that are effective for opening CTOs (chronic total occlusions),” said Dr. Charles Bailey, interventional cardiologist of Heart Endovascular & Rhythm of Texas. “If you can’t get those vessels open, the only alternative is surgical, and unfortunately with surgical procedures, it runs the risk of infection. This laser and catheter is unlike any other device because of its design. The fact that you can open up a vessel that’s been closed for a long time and not have to place a stent in it and not have to operate on a patient is phenomenal.”

The device is a catheter and excimer laser system for the treatment of complex and diffuse arterial blockages in the lower vessels. The single-use catheter produces a lumen while minimizing trauma to the vasculature. It is a full catheter tip forward cutter, without the “dead-space” of fiber optic bundle catheters. The DABRA laser photochemically ablates arterial blockages, reducing calcium, thrombus and atheroma, minimizing downstream debris. The portable laser weighs about 100 pounds. DABRA is covered by most private insurance carriers and Medicare.

The Heart Endovascular & Rhythm of Texas is the first outpatient facility in Texas to commercially work with Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, to cross and treat arterial blockages via femoral artery access.”

“Patients who have had the procedure have matched DABRA’s clinical study results, highlighting the efficacy and safety of this treatment to date, with zero adverse events,” said Dean Irwin, CEO, Ra Medical Systems. “We are thrilled to bring the DABRA system to patients and doctors in San Antonio in the treatment of Peripheral Artery Disease. With shorter procedure times, better patient outcomes and the procedure being less expensive, it’s a win-win-win for patients and their doctors and the healthcare system.”

Rhythm Endovascular & Heart Institute of Texas cath lab is working with Ra Medical Systems to be part of the next phase of clinical trials for coronary CTOs.

DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) changes the paradigm of vascular treatments clinically and economically, continuing Ra Medical Systems’ decade-long successful track record of delivering better, safer, faster and less-expensive solutions to treat complex and chronic medical conditions. Compared to other treatments for arterial blockages, Ra Medical Systems’ DABRA has shorter procedure times, better patient outcomes and is less expensive. Combined with its safety profile and versatility, these DABRA advantages may reduce the costs that are associated with treating Peripheral Artery Disease and ultimately lead to greater patient access to, and success with, interventional procedures.

According to the Centers for Disease Control and Prevention (CDC), approximately 8.5 million people in the United States have PAD, including 12-20% of individuals older than age 60 and people of Hispanic origin may have similar to slightly higher rates of PAD compared to non-Hispanic whites. Risk factors for PAD include smoking, high blood pressure, atherosclerosis, diabetes, and high cholesterol.

Peripheral Artery Disease is the leading cause of limb amputationsMore than 200 million people worldwide, including approximately 8.5 million Americans, suffer from Peripheral Artery Disease, a life-threatening condition in which the arteries that carry blood from the heart to the legs and arms narrow and become blocked. In the U.S. and Europe, Peripheral Artery Disease is responsible for approximately 240,000 amputations every year. Nearly one-quarter of these patients die within 30 days and almost half within a year of their limb amputation.