Boston Scientific, a developer, manufacturer and marketer of interventional cardiac medical devices, has reported the completion of patient enrollment in the Small Vessel and Long Lesion trials of its Platinum clinical program.
Platinum is a pivotal, randomized, controlled clinical trial program designed to support Administration and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element Stent. The company has received CE Mark approval for this product in October 2009.
Boston said that the trials are designed to compare the platinum chromium Promus Element Everolimus-Eluting Stent system to matched historical control groups of patients treated with the Taxus Express2 Paclitaxel-Eluting Stent System.
The Promus Element Stent is designed for coronary stenting. The new stent architecture and company’s alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.
In the US, the Promus Element Stent is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
The Small Vessel trial has enrolled 94 patients with de novo lesions greater than or equal to 2.25 to less than 2.50mm in diameter and less than or equal to 28mm in length. The Long Lesion trial has enrolled 102 patients with de novo lesions greater than 24 to less than or equal to 34mm in length and greater than or equal to 2.50 to less than or equal to 4.25mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.
Hank Kucheman, executive vice president and group president of cardiology, rhythm and vascular divisions at Boston Scientific, said: “Boston Scientific has led the way in developing drug-eluting stents for small vessels and long lesions. The Taxus Express Atom Stent and our more recent Taxus Liberte Atom and Taxus Liberte Long Stents have been adopted enthusiastically by our physician customers.
“The evaluation of a thin-strut, platinum chromium stent with a new drug offering reconfirms our commitment to providing the most complete range of solutions and sizes for physicians and their patients.”