Medtronic (NYSE:MDT) said today that it launched a clinical trial to evaluate the use of its In.Pact paclitaxel-coated percutaneous transluminal angioplasty balloon catheter in patients with below-the-knee peripheral arterial disease.
The company treated its 1st patient in the In.Pact BTK study, performing the procedure on a patient with critical limb ischemia.
“The 1st patient enrollment in the In.Pact BTK study marks a landmark milestone in identifying a treatment option for below-the-knee PAD,” Dr. Antonio Micari of Maria Cecilia Hospital said in prepared remarks. “Given the chronic nature and co-morbidities of this disease, there is a critical need for treatment options that are safe and durable. I look forward to continuing patient enrollment to evaluate the use of this DCB in treating this challenging disease state.”
Critical limb ischemia with peripheral arterial disease is associated with non-healing wound ulcers and amputation, according to the Fridley, Minn.-based company.
“Patency rates after conventional balloon angioplasty can be challenging in BTK disease, and we believe that a sustained patency could improve healing and reduce the need of target lesions revascularization and major amputation,” Dr. Francesco Liistro, chief of cardiovascular intervention at San Donato Hospital, added. “Multiple studies have evaluated DCBs in the superficial femoral arteries, but the need for clinically supported treatment options for below-the-knee PAD still remains. We look forward to participating in this significant trial to evaluate the In.Pact 0.014 DCB in a complex CLI patient population, particularly given the strong evidence for use of In.Pact Admiral in the SFA.”
The In.Pact BTK study is slated to enroll 60 patients. The primary endpoint is late lumen loss at 9 months in patients who received the DCB compared to standard percutaneous transluminal angioplasty.
“Peripheral artery disease below the knee is complex. With these prior analyses, we have developed an unmatched knowledge around the treatment of below-the-knee disease and CLI,” VP and GM of Medtronic’s peripheral biz Mark Pacyna said. “Together with our clinical investigators, we look forward to launching the In.Pact BTK study to evaluate the effect of the In.Pact 0.014 in patients with below-the-knee PAD.”