Resolute Integrity Drug-Eluting Stent

Company Medtronic, Inc.
Phone (877) 526-7890
Web www.medtronicstents.com
Key Features

  • First-and-only DES FDA-approved for diabetes patients
  • Stent platform provides superior deliverability and conformability
  • Robust RESOLUTE clinical program enrolled more than 5,000 patients
  • Powerful clinical performance across the patient spectrum
  • Biocompatible BioLinx polymer achieves 180-day drug elution

Several features distinguish the Resolute Integrity DES (Medtronic, Inc., Minneapolis, MN) from other stents, including its first-of-its-kind diabetes indication, superior deliverability, and its consistently powerful clinical performance across a broad spectrum of patients. The global RESOLUTE clinical program enrolled more than 5,000 patients, nearly 30% of whom had diabetes. Even with more than 70% of these patients coming from “all-comers” trials, the device showed compelling safety and efficacy results, equivalent to the market-leading stents and consistent among patients with and without diabetes. In the clinical trial conducted within the United States, patients implanted with the Resolute DES showed low rates of target lesion failure (4.7%), target lesion revascularization (2.8%), and stent thrombosis (0.1%) at 1 year. According to Medtronic, the Resolute Integrity DES has also been shown in bench testing to offer superior deliverability compared to the next generation alternatives due to a new stent platform that improves conformability, flexibility, and deliverability without compromising other important stent design characteristics like radial and longitudinal strength.


Edwards Intuity Valve System

Company Edwards Lifesciences
Phone +41 22 787 4438
Web www.edwards.com/eu
Key Features

  • Built on Edwards' proven valve platform
  • Rapid deployment for faster procedures
  • Designed to facilitate small-incision surgery

Edwards Lifesciences (Nyon, Switzerland) has begun a disciplined European launch of its Edwards Intuity valve system at centers participating in post-approval clinical studies. The system facilitates small-incision surgery and rapid valve deployment during aortic valve replacement procedures. It combines Edwards' proven pericardial valve technology with innovations from its TAVI program via a novel delivery system and a cloth-covered, balloon-expandable, stainless steel frame.

The TRITON trial evaluated the feasibility, safety, and performance of the Edwards Intuity valve system in Europe and demonstrated > 40% reductions in cross-clamp and bypass times compared to the Society of Thoracic Surgeons database. Furthermore, 51% of patients in the TRITON trial were treated via minimally invasive surgical approaches compared to 12% in the German National Database (2010) in isolated AVR procedures.“This system includes unique features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity,” said Prof. Michael Borger, MD, PhD, Associate Director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany and TRITON investigator.