The North Dallas Research Associates (NDRA) and its private practice, Cardiac Center of Texas, have announced their participation in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial. TOBA II BTK is a study that offers physicians a new option to treat patients suffering from advanced peripheral artery disease (PAD) or critical limb ischemia (CLI). Using the Tack Endovascular System, the innovative technology is designed specifically to repair dissections following standard balloon angioplasty in the popliteal and tibial arteries with minimal stress to the vessels.

"We're very excited to enroll the first patient in Texas to be treated in this groundbreaking clinical study," said Dr. M. Akram Khan, Cardiologist at Cardiac Center of Texas. "TOBA II BTK provides the latest vascular technology for those in the Dallas area suffering from advanced PAD."

PAD is a disease of the blood vessels in the legs and feet that occurs when arteries become narrow or clogged and don't receive enough blood flow to meet the body's needs. A recent analysis suggests more than 8 million Americans have peripheral artery disease, with 12-20 per cent of individuals ages 65+ being affected. When left untreated, PAD can lead to critical limb ischemia (CLI), a more serious form of the disease. There are more than one million people in the United States living with CLI. CLI patients experience similar symptoms to PAD patients; however, CLI symptoms can significantly increase in severity from pain when resting, to open sores, to life-threatening conditions like gangrene, and can eventually require limb amputation in some patients. According to the US Department of Health and Human Services, clogged arteries in the legs, just like clogged arteries in the heart, put individuals at risk for heart attack or stroke.

The Tack Endovascular System is equipped with self-sizing technology that allows one Tack implant to fit arteries ranging from 1.5mm to 4.5mm in diameter. This flexibility eliminates the need to precisely size the device to the arterial diameter, which is necessary with conventional stents. The device then allows physicians to "spot treat" the vessel only where dissections are present, rather than leave dissections untreated or covering them with large metal stents. This technique minimizes the amount of implanted metal and reduces vessel trauma and inflammation.

"Advanced PAD and CLI are large areas of fast-growing unmet need, both clinically and from a health economics perspective," added Dr. Khan. "Patients with CLI suffer from debilitating symptoms and have few effective treatment options. It is important for the medical community to collaborate in this study to further the treatment options for patients with such advanced disease."