A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported at the EuroPCR meeting, winding down today in Barcelona, that it has received CE mark for its Taxus Liberté Long paclitaxel-eluting coronary stent system, allowing doctors to treat longer coronary artery lesions with a single stent. Taxus Liberté Long is the longest available drug-eluting stent.

The Taxus Liberté Long is a specialty stent designed for more efficient stenting of long lesions (> 32 mm). Until now, patients with longer coronary lesions have required two or more overlapping stents to cover the lesion, increasing procedure time and cost. In the ARRIVE 1 and 2 registries (n = 10,376 lesions), 10% of lesions required overlapping stents. This new stent allows doctors to reduce the number of stents that they use, thereby simplifying the procedure, the company said.

"Long lesions can now be treated with one Taxus Liberté stent instead of two," said Jeff Goodman, president of Boston Scientific International. "The range of TAXUS Liberté stent sizes now available addresses the complexity of coronary artery disease and allows clinicians to choose the best stent for each patient."

The new stent combines a 38 mm length with four diameters (2.75, 3.0, 3.5, and 4.0 mm) and offers the flexibility and conformability of the Taxus Liberté stent for the management of long lesions in a range of artery sizes. It is CE marked for all of the same indications as the Taxus Liberté stent system and can be used to treat de novo lesions as well as restenotic lesions, total occlusions, and acute myocardial infarction.

The TAXUS Liberté stent system is now CE marked and available outside the U.S. in 58 sizes in diameters from 2.25 mm to 5.0 mm and lengths from 8 mm to 38 mm.

In other news from EuroPCR: Abbott Laboratories (Abbott Park, Illinois) reported positive results from the ABSORB trial, which the company said is the world's first clinical trial evaluating the safety and performance of a fully bioabsorbable drug eluting stent platform for the treatment of coronary artery disease.

Nine-month results from the first 30 patients in the trial, presented at the meeting, demonstrated no stent thrombosis and a low (4%, one patient) rate of major adverse cardiac events (MACE), such as heart attack or repeat interventional medical treatment.

The results confirm the six-month findings from ABSORB, which were reported in March, and show no new adverse events between six and nine months.

Abbott's everolimus eluting bioabsorbable stent is made of polylactic acid, a biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and provide support until the blood vessel heals.

Unlike a metallic stent however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.

Abbott said it will unveil an updated, bioabsorbable stent design at the meeting that will be used in the next cohort of patients enrolled in the ABSORB trial. The new stent features improved radial strength, which is intended to maintain vessel expansion so blood can flow through.

The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety; MACE and stent thrombosis (blood clot formation) rates at 30, 180 and 270 days, with an annual follow-up for up to five years, and successful deployment of the bioabsorbable drug eluting stent.

Other endpoints include follow-up measurements assessed by X-ray angiography, intravascular ultrasound, and state-of-the-art imaging modalities at 180 days and two years.

Three-year data from the SPIRIT FIRST trial demonstrated no additional MACE and no late stent thrombosis in patients treated with either Abbott's V everolimus-eluting coronary stent system or its Multi-Link Vision metallic coronary stent.

Additionally, data presented from a meta- (combined) analysis of SPIRIT II and SPIRIT III trials at nine months reaffirmed the superiority of Abbott's Xience V compared to Boston Scientific's Taxus paclitaxel-eluting coronary stent system in a variety of measures, the company said.

Specifically, data from the meta-analysis demonstrated that the Xience V was superior to the Taxus stent in reducing the occurrence of major adverse cardiac events in patients (4% Xience V treated patients vs. 8% Taxus treated patients). The Xience V also reduced the number of retreatments in patients due to ischemia, or lack of blood supply (ischemic target lesion revascularization, TLR) (2.4% Xience V vs. 5.1% Taxus). The Xience also showed a reduction in the amount of in-stent binary restenosis renarrowing in the vessel within the length of the stent (1.9% Xience V vs. 4.9% Taxus).

Abbott said it expects to complete submission of its premarket approval application for the Xience V system this quarter.