Boston Scientific wins FDA approval for Apex PTCA dilatation catheter

According to the company, the Apex catheter is a high-performance pre-dilatation balloon catheter developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. It is available for distribution in both Monorail and over-the-wire catheter platforms.

The Apex catheter represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment inner shaft for improved pushability and flexibility. Additionally, it has a redesigned tip with the same low profile as the Maverick PTCA dilatation catheter for excellent turning and wire tracking, the company said.

It is available in a wide array of balloon diameters from 1.5mm up to 5mm, with balloon lengths ranging from 8mm up to 40mm (for select diameters).

The Apex catheter is said to be the advanced technological development by Boston Scientific intended to improve the management of patients with coronary atherosclerosis undergoing percutaneous coronary intervention.

Hank Kucheman, senior vice president and group president of cardiovascular at Boston Scientific, said: “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. 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.”