Cook Medical (Bloomington, Indiana) has received FDA clearance to market its newest balloon dilatation catheter, the Advance 35LP. The company said the device is intended for use in patients with lesions in the femoral, iliac and renal arteries and rounds out Cook's line of low-profile PTA balloons.
The Advance line comprises three low-profile balloons (14LP, 18LP, 35LP) that range in size and composition to treat lesions in the peripheral arteries as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas, Cook said.
The company said the Advance 35LP will play an integral part in its Leg Therapy Program, an initiative geared toward helping physicians address the anatomical challenges of treating peripheral vascular disease (PVD) and deliver clinically effective interventional solutions to the patients who need them most. Commonly associated with diabetes, hypertension and coronary disease, PVD can result in amputation or death if left untreated, Cook noted. According to the company, "few are aware of the minimally invasive treatment options available apart from amputation or surgical bypass, the latter of which is the current gold standard in treating this disease."
"As you know, Cook has been working very hard on the Leg Therapy Program and part of the Leg Program is the tools doctors need [to treat PVD], and obviously balloons are a key part of that," Rob Lyles, VP and global business unit leader of Cook's peripheral intervention division, told Medical Device Daily. "The balloon piece of that for us is this Advance line of balloons."
The Advance 35LP balloon, compatible with a .035-inch wire guide, is designed to address common above-the-knee blockages. The Advance 18LP, compatible with a .018-inch wire guide, is geared toward the femoral artery and popliteal region of the leg. The Advance 14LP, compatible with a .014-inch wire guide, is reserved for treatment of the most tortuous anatomies of the lower leg, including the popliteal and infrapopliteal arteries.
Cook aims to offer a full complement of tools for PVD "because when a physician gets to that patient and they are about to start treatment, a lot of times they just don't know what they're getting into," Lyles said. "They need tools that will get them anywhere they need to go, and will be able to deal with all the kinds of shapes of lesions" that they might encounter.
Lyles said the Advance 35LP is more of a "work horse" balloon, meaning that it is a balloon that will work in a lot of different situations and has a lot of unique characteristics to it.
Cook said that each balloon in the Advance line features a low crossing profile and small-sheath compatibility, which helps reduce the need for an invasive arterial entry and may shorten patient recovery time. Advanced thermal setting of the balloon folds improves rewrap and sheath pull-back, and a unique double-lumen shaft construction using optimized nylon-blend material reduces balloon inflation/deflation time and improves pushability while maintaining kink resistance, the company noted.
As the awareness of peripheral artery disease increases, patient volumes are going up and doctors are treating more patients, more difficult patients and are seeing more and more types of lesions, Lyles said.
When asked about the competitiveness of the balloon market, Lyles told MDD that "in general, globally, the balloon market is a very competitive market." He said in places like Europe there are "multiple" competitors out there including a lot of smaller companies as well as what he called the "big five" – Cook, Cordis (Miami Lakes, Florida), Boston Scientific (Natick, Massachusetts), C.R. Bard (Murray Hill, New Jersey) and Abbott (Abbott Park, Illinois). Those same "big five" companies are also prevalent in the U.S. balloon market, he noted. The U.S. balloon market is "certainly competitive," Lyles said, "but there is still a lot of space in front of us." With its "state of the art, unique technologies," there is even more potential going forward, he said, and Cook sees an opportunity to go from a 5% to 10% market player up to a 30%-plus range.
Lyles said the Advance 35LP is also important because it fits within a larger picture.
"As we go to market with these tools a product certainly stands on its own, but a problem also occurs in a context and that context is the procedure itself," Lyles said. What's unique about Cook, he explained, is that it is one of the few companies that actually have a full offering in the space from initial access such as the guide wires, to the sheaths, to the treatment device itself such as the balloon or the stent. So, Cook customers can get a full line of products from a single vendor, he said.