Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-eluting balloon, designed to treat peripheral artery disease, showed better target lesion revascularization rates after 6 months than rival C.R. Bard‘s (NYSE:BCR) Lutonix DEB.
Results from the In.Pact SFA trial, announced April 5 at the Charing Cross international symposium in London, showed TLR rates of 1.4% for the In.Pact Admiral device, compared with 6.4% for the control arm. Bard’s Lutonix device and the control arm in its trial both showed TLR rates of about 3% at 6 months.
Investors reacted by shaving about 1% from BCR shares this morning, sending them to $146.57 apiece as of about 11 a.m. MDT shares were up 0.7% to $61.99 each – despite significant differences in the designs of the respective trials. Both Medtronic and Bard have said that their devices met their 12-month endpoints, but Bard has yet to release that data from the Levant-2 trial.
The Medtronic device showed TLR rates of 2.4% after 12 months, compared with 20.6% for the control arm, and primary patency rates of 82.2% for the DEB cohort and 52.4% for the control group. For its part, Bard is letting the FDA get the 1st look at its 12-month data.
Medtronic plans to include the 12-month data in its next pre-market approval submission to the FDA, which is slated to be finalized by the end May, cardiac & vascular president Mike Coyle told analysts during a conference call discussing the results. Bard filed the final module of its PMA in November 2013.
"The results of this rigorously conducted randomized controlled trial warrant a review of current treatment guidelines for peripheral artery disease in the lower extremities," principal investigator Dr. Gunnar Tepe, of RoMed Klinikum in Rosenheim, Germany, said in prepared remarks. "In fact, they should lead to a reconsideration of how we treat patients with claudication, as the highest level of clinical evidence now distinguishes the In.Pact Admiral drug-coated balloon as a primary therapy for atherosclerosis in the [superficial femoral artery]."
"Based on the addition of these compelling new data to the positive results of previous studies, we see a path to establishing a new standard of care for SFA disease with an optimized and trusted medical technology," added endovascular therapies president Tony Semedo. "The In.Pact Admiral drug-coated balloon has the lowest reported revascularization rate of any medical technology for the treatment of SFA disease; and in this particular vessel bed, our device also has the highest reported primary patency rate, with minimal need for durable implants."