Cardiovascular Device Update

Abbott Laboratories (Abbott Park, Illinois) last week reported completing final submission of its premarket approval (PMA) application to the FDA for its Xience V everolimus-eluting drug-eluting stent (DES) system to treat coronary artery disease.

The PMA submission includes safety and efficacy data from the XIENCE V SPIRIT family of clinical trials, which demonstrated superior results for XIENCE V over the Taxus paclitaxel DES system, from Boston Scientific (Natick, Massachusetts), in the primary endpoint of reducing vessel re-narrowing (angiographic late loss).

The Xience is the second of the second-generation DES devices to be submitted to the FDA for approval.

The first is the Endeavor DES from Medtronic (Minneapolis), which completed the fourth and final module of its submissions to the agency in January.

The company is pointing for system approval in the first half of 2008, with expectations of rapid market uptake in its battle with the Taxus and the Cypher, as well as the Endeavor.

A spokeswoman for Abbott told CDU: "We're very confident about gaining competitive market share in the U.S. We think that Xience V has the right components to make it a really competitive product in the United States. All of the engineering and development that's gone into the design of the Xience V we think has resulted in a next-generation product that holds great potential for treating coronary artery disease."

She said that the Xience, launched in Europe and Asia in October 2006, has captured market share there in the low double digits and expects to improve that to the mid to high twenties by year-end. (The Endeavor DES won CE-marking in July of 2005.)

She said Abbott is predicting success in the U.S. similar to that overseas.

"This is the first-ever PMA submission to include head-to-head clinical trial results that demonstrated superiority of one drug-eluting stent over another in the primary endpoint," said John Capek, PhD, senior vice president, Abbott Vascular. "With the filing of our third and final PMA module, we have submitted all the pre-agreed data necessary to complete our application for XIENCE V approval in the United States. We look forward to bringing XIENCE V to U.S. physicians and patients."

Abbott's system utilizes the Multi-Link Vision coronary stent platform, which the company acquired from Guidant (Indianapolis) as part of Boston Scientific's acquisition of Guidant last year.

Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant in April of 2006 as part of Federal Trade Commission requirements for regulatory approval of the Guidant/Boston Sci deal. In another part of that deal, the final PMA module that Abbott submitted also requests FDA approval for the Promus everolimus-eluting coronary stent system, a private-label version of the Xience V, which will be distributed by Boston Scientific.

Xience moved to the top of Abbott's to-do list when in late 2006 it scrapped its ZoMaxx DES program, based on analysis indicating the superiority of the Xience V (Medical Device Daily, Oct. 4, 2006).

Med-tech analyst Rick Wise of Bear Stearns (New York) wrote in a research note that his firm expects Xience V to launch in 2Q08, though he added that there is uncertainty about whether the company will have to go before an FDA panel, given the recent questions concerning DES devices.

"It is still unclear whether Xience will go through an FDA panel, though given recent DES safety concerns it is possible that a panel will be required. But, even with a panel, [Bear Stearns] management is still comfortable with a 1H08 launch expectation."

Wise said that Xience is poised to become the DES market leader.

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