Boston Scientific Allies with Philips Healthcare to Bolster Imaging Equipment Offering; Expands Cath

Boston Scientific Allies with Philips Healthcare to Bolster Imaging Equipment Offering; Expands Catheter Product Offering As Well
Boston Scientific Corp. has announced a partnership with Philips Healthcare, the objective of which is to allow Philips to sell Boston Scientific imaging equipment in connection with its Allura Xper catheterization (cath) lab systems worldwide.

The Boston Scientific iLab ultrasound imaging system is a platform for the company’s imaging catheters. The iLab system features heightened image quality and allows physicians the ability to choose from a variety of imaging catheters for coronary, peripheral and intracardiac applications, according to the company. The system is compatible and can be integrated with all major X-ray systems including the Philips Allura Xper system. Their agreement enables Philips to offer customers an integrated imaging solution that is compatible with current and next-generation Boston Scientific imaging catheters.

“Boston Scientific is pleased to collaborate with Philips and establish the foundation for an ongoing relationship,” said Isaac Zacharias, general manager of Boston Scientific’s Imaging business. “As premier providers of medical technology for cardiologists and electrophysiologists, this collaboration is expected to expand the ability of Boston Scientific and Philips to offer integrated solutions that improve ease of use and workflow for our worldwide customers.”

“This collaboration is a further step in Philips’ strategy to offer seamlessly integrated interventional solutions. Philips works with companies like Boston Scientific to continuously enhance the integrated functioning of our cath labs and further enhance the user experience,” said Bert van Meurs, senior vice president and general manager of Interventional X-Ray at Philips Healthcare.

Philips Healthcare is a division of Royal Philips Electronics based in the Netherlands, and has U.S. headquarters in Andover, Mass. The company produces various medical devices and technologies.
Boston Scientific steadily has been expanding its catheter-related products. The company received CE Mark approval for its Innova self-expanding bare-metal stent system (which includes a catheter shaft), and will launch the stent in Europe and other CE Mark countries immediately.

The stent is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Peripheral vascular disease (PVD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries of the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability. In Europe, PVD affects 13 million people or one in 20 people older than 40 years of age.

The Innova stent system consists of a nitinol (a metal alloy of nickel and titanium) self-expanding, bare-metal stent loaded on a low-profile delivery system. The architecture features a closed-cell design at each end of the stent for more consistent deployment, and an open-cell design along the stent body for improved flexibility. The stent features a tri-axial catheter shaft designed to provide added support and placement accuracy as well as radiopaque markers to enhance visibility. The stent is 6F compatible and is available in sizes from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.

“Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates,” said Mauro Gargiulo, M.D., physician at Sant’Orsola-Malpighi in Bologna, Italy, who performed the first procedure using the Innova stent in Europe. “The unique design and stent architecture used in the Innova Stent platform provide excellent radial strength, flexibility and durability which are critical to sustaining patency in treated SFA and PPA lesions.”

The stent is not available in the United States yet, but patient enrollment continues in the SuperNOVA clinical trial to support the company’s application for U.S. Food and Drug Administration approval of the device.

The prospective, single-arm, non-randomized trial will evaluate the safety and effectiveness of the Innova Stent in patients with stenosis of the SFA, PPA, or both. Enrollment is planned for up to 300 patients at 50 sites in the United States, Canada and Europe; the expected date of completion is within the first half of 2013.

Boston Scientific is based in Natick, Mass., and its imaging business includes a line of intravascular ultrasound and intracardiac echocardiography imaging catheters. These devices enable physicians to assess diseased arteries and intracardiac structures to aid in appropriate diagnosis and treatment.