Abbott Laboratories (Abbott Park, Illinois) late 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.

While that chronology has been seen as giving Medtronic the lead position, at least one device analyst firm, JP Morgan, has cited problems with Endeavor’s efficacy and delivery and projected that Xience will gain the larger market share and quickly elbow aside the two first-generation devices marketed in the U.S.: the Taxus and the Cypher from Cordis (Miami Lakes, Florida).

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 Medical Device Daily: “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.”

The company filed its first module in the submission process in July 2006.

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).

While declining to specify a sale price for the Xience V system, the Abbott spokeswoman did say that it would be “priced competitively” with current DES devices on the market.

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.

“Based on impressive SPIRIT III data, Xience seems well-positioned to gain share quickly in the U.S. upon approval,” he said. “We currently expect 25% Xience share in the 2008 U.S. DES market and 35% share in 2009.

Beyond FDA approval, Wise said the next likely Xience catalyst may be two-year SPIRIT II follow-up data in 300 patients, possibly at the American College of Cardiology (Washington) meeting to be held in Chicago in March 2008.

Abbott’s PMA submission for the XIENCE V includes data from the following clinical trials:

SPIRIT FIRST, a randomized trial comparing the Xience V everolimus-eluting coronary stent system with the Multi-Link Vision metallic stent system. SPIRIT FIRST met its primary endpoint and demonstrated no stent thrombosis out to three years.

SPIRIT II, a randomized clinical trial evaluating Xience V vs. Taxus in Europe and Asia Pacific. SPIRIT II met its primary endpoint and demonstrated the superiority of Xience V to Taxus on in-stent late loss at six months.

SPIRIT III, a large-scale, randomized pivotal clinical trial comparing Xience V to Taxus in the U.S., with additional registry arms in the U.S. and Japan. SPIRIT III met its primary endpoint and demonstrated the superiority of Xience V to Taxus on in-segment late loss at eight months.

Late last month Medtronic reported enrollment of the first patient in its Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT), an 8,800-patient study that will compare the Endeavor against the Cypher. The Endeavor elutes the drug zotarolimus, while the Cypher elutes the drug sirolimus (Medical Device Daily, May 29, 2007).

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