TCT: Bard, Medtronic release long-term data for their dueling drug-coated balloons

Medtronic and C.R. Bard released data about their competing drug-coated balloons for femoropopliteal peripheral arterial disease (PAD) at the TCT conference in San Francisco.

IN.PACT Admiral--Courtesy of Medtronic

Medtronic ($MDT) presented new data from a two-year randomized controlled trial of its IN.PACT Admiral drug-coated balloon to treat that indicated the device's superior outcomes compared to standard angioplasty are long-lasting. That's important because drug-coated balloons are designed to reduce the usage of leg stents by applying drugs to the site of the blocked arteries. Leg stents are sometimes necessary, but (more so than coronary stents), they are plagued by concerns about in-stent restenosis (the reappearance of plaque after stenting) and the potential for fractures.

Proof of the durability of the benefits of a drug-coated balloon has been long awaited, "because there's nothing left behind," Dr. David Cohen of Saint Luke's Mid America Heart Institute in Kansas City, MO, told MedPage Today, referring to the decrease in stenting following use of the device.

The data show that Admiral patients displayed continued superiority of outcomes over those treated with a standard angioplasty balloon. In the Medtronic IN.PACT SFA study, the primary patency rate, or restoration of blood flow through the artery treated with the company's balloon was 78.9% compared to 50.1% for the group treated with standard angioplasty, the company said. The rate of clinically driven target lesion revascularization (or reintervention) was 9.1% with the drug-coated balloon against 28.3% among those treated with a standard balloon.

The trial results come as fierce competition between Medtronic and C.R. Bard's ($BCR) Lutonix paclitaxel-coated balloon heats up. Earlier at the Transcatheter Cardiovascular Therapeutics (TCT) conference being held in San Francisco, C.R. Bard released results from its LEVANT 2 trial. The IN.PACT study had 331 enrolled patients in the U.S. and Europe.

Lutonix--Courtesy of C.R. Bard

Bard's Lutonix drug-coated balloon achieved a freedom from target lesion revascularization rate of 94.3% in femoropopliteal arteries at one year among 631 patients whose data was in a global registry. Based on interim data from 170 patients who enrolled earlier in the study, a freedom from TLR rate of 93% at two-years, the company said.

Unlike in Medtronic's trial, Bard's data shows some indications of late catch-up in restenosis between the one- and two-year follow-ups, which "highlighted that not all drug-coated balloons are the same," said Dr. John Laird of the University of California, Davis Vascular Center in Sacramento. He is one of the lead investigator's of Medtronic's trial, and is a paid consultant for the company.

Laird went on to say the U.S. practice has been shifting toward drug-coated balloons as an alternative to femororpopliteal stents, MedPage Today reported. Indeed, both Medtronic and Bard say their devices are off to good starts since FDA approval last year or early this year, although they haven't given precise sales numbers.

And in August, the Centers for Medicare & Medicaid Services recognized the devices' innovative nature and clinical benefits by giving both companies new technology add-on payments for their drug-coated balloons. The bonus reimbursement is designed to help hospitals cover the costs of treating patients with the devices.

Between 8 million and 12 million people in the U.S. suffer from PAD, according to Medtronic estimates. About 450,000 patients in the U.S. get surgery to treat the condition, which is located in the leg's superficial femoral artery, where the disease strikes most often.

- check out Metronic's release
- see Bard's release
- read the MedPage Today story