Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Abbott Xience V stent trials

This article was originally published in The Gray Sheet

Executive Summary

Company commences enrollment for its 1,125-patient, SPIRIT IV clinical trial to evaluate the everolimus-eluting coronary stent system against Boston Scientific's Taxus Express paclitaxel-eluting stent Aug. 14. The single-blinded, 40-site U.S. study will enroll more complex patients than evaluated in previous studies and include treatment of "up to three de novo...native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation," Abbott says. Patients will be randomized at a 2:1 ratio for treatment with either Xience V or Taxus. The primary endpoint will be "ischemia-driven target vessel failure at 270 days." Xience V, based on the Multi-Link Vision stent platform, will debut in Europe this year (1"The Gray Sheet" July 24, 2006, p. 9)...

You may also be interested in...

Abbott Makes First Xience Submission To FDA As Guidant Biz Boosts Sales

Abbott kicked off the premarket approval submission process July 19 for the Xience everolimus-eluting coronary stent, taking a step closer to capitalizing on its recent acquisition of Guidant's vascular business

Amunix Raises $117m To Take Novel T-Cell Engager Into The Clinic

Amunix’s XTEN technology for half-life extension and precise drug delivery has been used by multiple partners over the past 15 years, but now the firm is building its own cancer therapy pipeline.

Global Medtech Guidance Tracker: February 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts