Medical Device Daily Associate

Boston Scientific (Natick, Massachusetts) reported that it has completed enrollment in its ATLAS clinical trial for the Taxus Liberté coronary stent as a platform for its paclitaxel-eluting coronary stent system.

Liberté is the next generation to the company's highly successful Taxus Express2, which is currently the worldwide leader in the coronary stent market.

The ATLAS trial is a global, multicenter pivotal study designed to support FDA approval of the Liberté stent system. It is assessing the safety and efficacy of a slow-release dose formulation paclitaxel-eluting stent system for the treatment of coronary artery disease. Thus far, ATLAS has enrolled 872 patients at 72 sites in the U.S., Canada, Austra-lia, New Zealand, Singapore and Hong Kong.

The primary endpoint for the study is target vessel revascularization at nine months. Enrollment began in August 2004.

Enrollment in the trial began last August (Medical Device Daily, Aug. 27, 2004) and was originally scheduled to enroll 822 patients at 60 international sites.

In addition to the ATLAS trial, the Taxus Liberté program includes several expansion studies for long-lesion stenting, small-vessel stenting and direct stenting of coronary lesions. The expansion studies are expected to begin enrollment in the next several weeks, as stated by Boston Sci.

The company received the CE mark for the bare-metal Liberté stent system in December 2003 and plans to launch the DES version of the system in Europe later this year. The system was launched in 18 other international markets in January.

“I am very pleased that enrollment has concluded in this pivotal study so quickly,“ said John Ormiston, MD, interventional cardiologist at Mercy Hospital and Green Lane Cardiovascular Unit (Auckland, New Zealand), and co-principal investigator of the ATLAS study. “We are excited about the potential for the new Liberté stent design to provide clinicians easier access to vessels indicated for drug-eluting stent treatment.“

The stent features the Veriflex stent design, which Boston Scientific referred to as “a highly flexible cell geometry with thin struts and uniform cell distribution.“

The company has said that this new platform offers improved deliverability and conformability in challenging anatomy. It also features the enhanced TrakTip catheter tip, mounted on the Maverick2 delivery catheter, which the company said provides better lesion crossability. In addition, TrakTip has a low lesion-entry profile, which further improves crossability, it said.

On a related Liberté note, Boston Scientifc reported yesterday that it has initiated enrollment in what it said is the world's largest drug-eluting stent registry.

The Taxus OLYMPIC registry plans to enroll more than 30,000 patients at more than 600 centers in the U.S., Europe and other international locations. The registry is designed to collect and analyze “real-world“ clinical outcomes data for the Taxus Liberté stent system in the treatment of patients with coronary artery disease.

The company said the registry will enroll patients in five phases, corresponding to the commercial introduction of the system in different regions of the world. The initial, transitional phase is enrolling patients from a limited number of international markets in which Boston Scientific launched the system in January. This phase will be followed by enrollment of patients from a broader number of international markets, then from European markets and finally from a two-phase U.S. enrollment.

Waqar Ahmed, MD, at King Fahed Armed Forces Hospital (Jeddah, Saudi Arabia) enrolled the first patient in the registry last week. Other physicians are scheduled to begin enrolling patients immediately. The first phase of the OLYMPIC registry will enroll 500 patients.

Boston Scientific acquired worldwide exclusive rights from Angiotech Pharmaceuticals (Vancouver, British Columbia) to use paclitaxel to coat its coronary stent products and has co-exclusive rights to other vascular and non-vascular products.