Medtronic Begins IN.PACT BTK Study in Europe

March 9, 2017—Medtronic plc announced the commencement of the IN.PACT BTK study in Europe to evaluate the effectiveness of a drug-coated balloon (DCB) in patients with below-the-knee (BTK) peripheral artery disease (PAD). The European study will evaluate the company's 0.014-inch In.Pact paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, which uses In.Pact Admiral drug-coating technology. The 0.014-inch In.Pact DCB does not have an approved investigational device exemption in the United States, advised the company.

According to Medtronic, IN.PACT BTK is a prospective, randomized, multicenter study that will enroll approximately 60 patients at four sites in Europe. The study's primary endpoint is late lumen loss at 9 months in patients who underwent treatment with the 0.014-inch In.Pact DCB compared to standard PTA.

The study also includes a wound care protocol, which provides additional safety controls and ensures patients undergo routine and standard monitoring by qualified wound care professionals.

Antonio Micari, MD, who performed the study's first procedure on a patient with critical limb ischemia (CLI), commented in Medtronic's announcement, "The first patient enrollment in the IN.PACT BTK study marks a landmark milestone in identifying a treatment option for below-the-knee PAD. Given the chronic nature and comorbidities 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." Dr. Micari is with Maria Cecilia Hospital in Cotignola, Italy.

Francesco Liistro, MD, who is Chief of Cardiovascular Intervention at San Donato Hospital in Arezzo, Italy, added, "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. Liistro continued, "Multiple studies have evaluated DCBs in the superficial femoral arteries (SFA), 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."