Boston Scientific (Natick, Massachusetts) said it has completed patient enrollment in the workhorse portion of its PLATINUM clinical program. PLATINUM is a global, randomized, pivotal controlled trial designed to support approval of the platinum chromium Promus Element everolimus-eluting coronary stent system in the U.S. and Japan.
The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites worldwide, and completed enrollment two months ahead of schedule, the company said.
The PLATINUM workhorse trial evaluates the new Promus Element everolimus-eluting coronary stent in comparison with the current Promus stent, which uses the same drug dose and polymer on an earlier cobalt chromium alloy stent design.
Jeff Lemaster, VP of stent marketing at Boston Scientific, told Medical Device Daily that because the trial enrollment was completed about two months ahead of schedule, the company is in a better position to be able to bring the new Promus Element stent to the U.S. market "hopefully" in early to mid 2012. "I think the biggest reason it's significant for us is the amount of time it takes you to enroll a trial is the biggest waiting game," he said.
Lemaster said the company would initially follow the patients in the PLATINUM trial for 12 months, which is where the primary endpoint data will be collected. The company will continue to follow the patients for five years, he said.
Two parallel sub-trials will evaluate the Promus Element stent in small vessels and long lesions, Boston Scientific said. In addition to the Promus Element everolimus-eluting stent, the company said it is developing additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial compares the TaxusS Element stent to the Taxus Express2 stent. The PERSEUS trial completed enrollment in October 2008, and the primary endpoint will be reported at the American College of Cardiology (Washington) conference in 2010, the company said.
"The brisk enrollment in the PLATINUM trial reflects the strong interest in this new platinum chromium stent platform," said Gregg Stone, MD, professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital and principal investigator of the trial.
Boston Scientific reported the beginning of patient enrollment in the PLATINUM clinical trial in February (Medical Device Daily, Feb. 4, 2009).
According to Boston Scientific, the Element stent platform features a platinum chromium alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to allow thinner struts, increased flexibility and a lower profile, while improving radial strength, recoil and visibility. In addition, all three Element stents incorporate the new Apex Dilatation Catheter technology, designed to enhance deliverability, the company noted.
Lemaster said that Platinum is also much more visible under X-ray, which is an added bonus.
"We are pleased to bring the next-generation Element drug-eluting stent platform another step closer to commercialization," said Hank Kucheman, senior VP and group president of Cardiovascular for Boston Scientific. "We are confident that the next-generation Element platform — to be offered in everolimus, paclitaxel and bare-metal versions — will further extend our global drug-eluting stent leadership."
Abbott (Abbott Park, Illinois) won FDA approval of its Xience V everolimus-eluting stent in July 2008, making it the second of the 2.0 family of drug-eluting stents to receive marketing approval in the U.S. The regulatory milestone was also a win for Boston Scientific, which shares profits from the device. Guidant (Indianapolis) had been developing the stent and when Boston Scientific acquired that company, it had to divest the stent to Abbott, but it retained the right to sell the same device as the Promus under a private-label arrangement (MDD, July 7, 2008).
Lemaster said that one key difference between the new Promus Element stent and the current Promus stent is that Boston Scientific will manufacture the device, rather than Abbott, and therefore will not have to share profits from it.
The Promus Element, Taxus Element and bare-metal Element stents are investigational devices and are not available for sale. Boston Scientific reported in May that it had launched the platinum chromium Taxus Element paclitaxel-eluting coronary stent system in select markets worldwide (MDD, May 20, 2009).
Amanda Pedersen, 229-471-4212