Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis.
For patients treated with bare balloons, half must have the procedure done again because their arteries have re-clogged. Stents improved that rate to 1 of every 3 or 4 patients, Mirviss told Drug Delivery Business News. But drug-coated balloons designed to control scar tissue formation can bring the rate down to 1 in 20 patients.
Boston Scientific (NYSE:BSX) has a prolific portfolio of peripheral intervention devices, including their Ranger paclitaxel-coated PTA balloon catheter. In a study of 105 patients with femoropoliteal lesions, the balloon yielded 86% primary patency and 91% freedom from total lesion revascularization at 12 months, lessening the need for re-interventions. Both findings were statistically significantly higher than the control arm of patients, who were treated with a bare balloon.
The company said last week that, based on these findings, Boston Scientific won approval to being enrolling patients in an investigational device exemption trial designed to compare the Ranger drug-coated balloon with a standard PTA balloon. The trial is slated to enroll up to 400 patients and will support regulatory submissions in the U.S. and Japan, according to the company.
Mirviss told us that a key component of its technology is the balloon itself – the Sterling balloon catheter.
“It has the highest market share as a base platform, so physicians are very familiar with the technology, which helps in terms of acute handling and the overall delivery of the product. It’s something that is well known to many physicians around the world,” he said. “Unlike other drug-coated balloons say that start with a new balloon that the coating is put on, you know we started with a market leading balloon and just applied our coating to it.”
The company’s peripheral business has a busy year ahead, with 20 ongoing clinical trials around the globe evaluating drug-eluting therapies for the treatment of peripheral artery disease. Robust clinical evidence is part of what makes Boston Scientific’s portfolio so strong, Mirviss said.
“I think the peripheral field has been somewhat fairly characterized as a field that doesn’t have robust clinical evidence and is emerging as a therapy,” he said. “Some companies may look at it and deliver the type of evidence that is solely required to get the regulatory approvals for the technology. We want to be the company that goes far beyond the base requirements and deliver the type of evidence so that physicians and hospital systems and payers can make well informed evidence based decisions.”
Boston Scientific is not the only major medtech player involved in developing drug-coated balloons for peripheral interventions. Earlier this week Medtronic (NYSE:MDT) touted 1-year outcomes of the company’s In.Pact Global Study, which evaluated its In.Pact drug-coated balloon in patients with peripheral artery disease.
In what Mirviss described as a 1st in the field, Boston Scientific is conducting a head-to-head trial to compare the performance of Medtronic’s In.Pact device with its own Ranger balloon. Data from the Compare trial is expected in January next year.
The company is also conducting a trial comparing Boston Scientific’s Jetstream atherectomy in combination with Ranger randomized against the Ranger drug-coated balloon alone.
This summer, the company plans to launch a 200mm version of its Ranger drug-coated balloon – the longest device of its kind on the market.
The Ranger balloon has CE Mark clearance in the European Union and Mirviss said the company has seen a lot of growth and interest in the European market for its DCBs.
“We kind of say, ‘Physicians can have it all with the Boston Scientific PAD portfolio,'” he said. “We’re the only company that has all of the bare tools like bare balloons and stents, atherectomy, drug-coated balloons, and drug eluting stents. No other company can offer that full portfolio of products.”