Boston Scientific Launches Stent Trial in New Zealand

An Auckland, New Zealand physician has performed the first patient implant of Innova, Natick, Mass.-based Boston Scientific Corporation’s drug-eluting stent (DES) system. The implantation launches the Majestic trial, designed to evaluate what is Boston Scientific’s first peripheral DES system.

The trial is projected to enroll 55 patients across 15 centers in Europe, Australia and New Zealand.

The Innova DES System is designed to restore blood flow in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The stent features a drug-polymer combination intended to facilitate optimal release of the drug and prevent restenosis, or narrowing, of the vessel. The first implant was performed by Andrew Holden, M.D., director of interventional radiology at Auckland City Hospital.

“The complex anatomy of the superficial femoral artery above the knee and the dynamic forces created by flexion of the knee create a challenging environment for implants like stents, leading to the potential risk of stent fracture and higher rates of restenosis,” said Professor Stefan Muller-Hulsbeck, M.D., Ph.D., deputy chairman of the Vascular Center Diako Flensburg and head of the department of diagnostic and interventional radiology/neuroradiology, Academic Hospitals Flensburg, Germany. “The Innova DES system combines the benefits of the clinically-proven drug Paclitaxel with architecture and stent design purpose-built for use in the SFA and PPA. The deliverability, flexibility and durability in combination with the anti-restenotic characteristics of the Innova DES System make it ideal for use treating lesions in these critical arteries.”

Professor Muller-Hulsbeck serves as principal investigator of the Majestic trial.

The Innova DES system consists of a paclitaxel-coated, nitinol, self-expanding stent loaded on a low-profile delivery system. The stent architecture features a closed-cell design at each end of the stent designed for more consistent deployment, and an open-cell design along the stent body for improved flexibility and fracture resistance. Deployment accuracy is facilitated by a tri-axial catheter shaft designed to provide added support and placement accuracy.

“Millions of patients around the world suffer the debilitating effects of peripheral artery disease (PAD), including amputation and an elevated risk for major cardiovascular events,” said Jeff Mirviss, president of peripheral interventions at Boston Scientific. “The Innova DES system builds upon the Boston Scientific leadership in both peripheral vascular devices and drug-eluting technologies, and we look forward to bringing this meaningful innovation forward to improve outcomes for patients with PAD.”

Peripheral artery disease is a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb. It is estimated that 12-14 percent of the general population is affected by PAD, according to a 2007 study that appeared in Vascular Health.