Medtronic has unveiled positive results from the IN.PACT BTK study evaluating its IN.PACT 0.014 drug-coated balloon (DCB) in critical limb ischemia (CLI) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.

The IN.PACT BTK trial is a multi-centre, randomised feasibility that evaluated the safety and effectiveness of the IN.PACT 0.014 DCB, in 50 participants across nine sites in Europe.

Under the trial,Medtronic’s 3.5μg/mm2 dose paclitaxel-coated balloon has been compared with conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries.

The effectiveness endpoint includes lumen loss, which compares the post-procedure lumen diameter compared to lumen diameter at nine months, along with sub-segmental late lumen loss, and called classic late lumen loss.

The safety endpoint includes a combination of freedom from device- and procedure-related death within 30 days, target limb amputation within nine months, and clinically driven limb revascularisation (CD-TLR) within nine months after procedure.

Medtronic Peripheral Vascular business vice president and general manager Mark Pacyna said: “Today’s milestone is the result of a close partnership between Medtronic and the clinical community to design a thoughtful BTK study to assess how the IN.PACT 0.014 DCB works on some of the most challenging lesions in critically ill patients with BTK disease.

“We are encouraged by the results of this feasibility study and are committed to investing in further BTK studies to serve this critical patient need.”

IN.PACT 0.014 DCB has similar formulation as IN.PACT Admiral and IN.PACT AV DCB

In the study, the patient group received DCB experienced a 53% reduction in sub-segmental late lumen loss and 32% lower late lumen loss compared to those who received PTA control, at nine months.

The study results showed no statistical difference in the safety composite endpoint within nine months between the DCB group and PTA control group.

The company said that the IN.PACT 0.014 DCB, used in the IN.PACT BTK study, deploys the same DCB formulation as its previous IN.PACT Admiral and IN.PACT AV DCB clinical programmes. In 2012, Medtronic has completed the IN.PACT DEEP study, which evaluated the safety and effectiveness of the previous generation IN.PACT Amphirion DCB.

The five-year study did not meet the effectiveness endpoint, and resulted in removal of IN.PACT Amphirion DCB from the market in 2013.

Medtronic aortic, peripheral and venous clinical research, medical affairs, and education vice president Simona Zannetti said: “As a result of our learnings from the earlier IN.PACT DEEP study, we now have a better understanding of this challenging vessel bed, as well as deep expertise in BTK clinical trial and product design.

“Unlike in the coronaries, patients with BTK disease have very long lesions. By evaluating late lumen loss at the sub-segmental level, we are better able to understand paclitaxel drug effect across the entire lesion.”