Since the mid-1990s Boston Scientific (Natick, Massachusetts) has claimed to be the market share leader for catheters used in angioplasty procedures. The company said last week that it stands a chance to increase its market share even more with its latest FDA-approved catheter. The company said that it received clearance from the federal agency to market its Apex PTCA Dilation Catheter.
PTCA (percutaneous transluminal coronary angioplasty) dilatation catheters are used in coronary angioplasty and stenting procedures to open arteries blocked by atherosclerosis, which if left untreated can cause heart attack and stroke. More than 870,000 people die from coronary artery disease in the U.S. each year.
"Apex is a high-performance predilatation balloon catheter that helps physicians cross the most challenging lesions," Jeff Mirvis, VP of marketing for Boston Scientific, told Medical Device Daily last week. "The device is on the forefront of dilatation catheter technology and uses a new Bi-Segment inner shaft improved pushability and flexibility. It has a redesigned tip with the same low profile as the Maverick PTCA Dilation Catheter for excellent turning and wire tracking."
Apex is poised to be an improvement over the Maverick by 25% and is an addition to build on the company's "Maverick legacy."
The newly approved device is available for distribution in both Monorail and Over-The-Wire (OTW) catheter platforms.
"The most important feature for Apex is its movability and more specifically, it's greater flexibility," Mirvis said.
It is available in a wide array of balloon diameters from 1.5 mm to 5.0 mm, with balloon lengths ranging from 8 mm to 40 mm (for select diameters). Both the Apex Monorail and OTW catheters are available in two different 1.5 mm designs — Apex Push Catheter and Apex Flex Catheter.
The Apex Push Catheter is designed to enhance pushability for tight lesions, while the Apex Flex Catheter is designed to enhance trackability for tortuous arteries. The two 1.5 mm Apex Catheter designs enable physicians to select the appropriate catheter based on the clinical situation.
"The Apex Catheter is a reflection of Boston Scientific's commitment to providing physicians with the most complete set of high-performance cardiovascular devices possible," said Hank Kucheman, senior VP and group president, cardiovascular. "As an established market leader, we listened to physicians' requests for improvements to existing balloon catheters, and responded with the advanced technology found in the Apex catheter."
The Apex catheter also has CE-mark approval.
"We don't have any human use in the U.S., but the response in Europe has been very positive," Mirvis said.
Apex is the most recent of a string of offerings from Boston Scientific focused on the management of patients with coronary atherosclerosis undergoing percutaneous coronary intervention (PCI). Last month the FDA approved the company's Carotid Wallstent Monorail Endoprosthesis for patients with carotid artery disease who are at high risk for surgery (Medical Device Daily, Oct. 27, 2008).
The Wallstent is the leading carotid stent in Europe and other international markets, according to the company. It is a self-expanding stent mounted on a rapid exchange delivery system, designed to re-open the carotid artery by treating stenosis, and improve blood flow to the brain.
A couple of weeks earlier at the Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium in Washington, GE Healthcare (Waukesha, Wisconsin) and Boston Scientific reported a collaboration focused on improving intravascular ultrasound (IVUS) workflow between the GE Healthcare Innova cardiovascular X-ray system and Boston Sci's iLab Ultrasound Imaging System (MDD, Oct. 14, 2008).
The collaboration is a continuation of what the company calls an "optimization through a broad range of devices, including ultrasound imaging to assess lesions and balloon catheters and drug-eluting stents to reopen blocked arteries. This broad portfolio of devices supports physicians' efforts to achieve safe and effective outcomes for their patients.
Boston Scientific also reported positive one-year results from the Intercontinental and European launch phases of its global Taxus OLYMPIA registry, which it said is the world's largest prospective, post-approval registry for a single drug-eluting stent (MDD, Oct. 17, 2008).
Outcomes from the 22,000-patient study are focused on high-risk lesion subgroups and patients with serious co-morbidities.