Medtronic has announced a preview of notable clinical studies that will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium (11–15 October, San Francisco, USA). The two-year results from the pivotal IN.PACT SFA clinical trial will be unveiled in a First Report Investigation presentation and data for the company’s CoreValve transcathter aortic valve implantation (TAVI) device will also be presented.
The two-year data from the IN.PACT SFA clinical trial are a follow up to the previously announced one-year data from the IN.PACT SFA clinical trial. The results will report patency out to two-years to investigate the durability and efficacy of IN.PACT Admiral for the interventional treatment of peripheral artery disease in the upper leg. The data will also be published simultaneously in the Journal of the American College of Cardiology (JACC), marking the first publication of two-year data evaluating the safety and efficacy of drug-coated balloons.
Additionally, Medtronic’s TCT agenda will feature several presentations that showcase rapid progression in the TAVI market. The one-year results from the CoreValve Evolut R System CE study will showcase clinical outcomes with the recapturable CoreValve Evolut R System; the first report of data from the Transcatheter Valve Therapies (TVT) Registry with the CoreValve System will reveal initial real-world outcomes with CoreValve; and several sessions will demonstrate the CoreValve System’s data from an Expanded Use Study evaluating performance in expanded patient populations, including patients with failed surgical aortic heart valves, end-stage renal disease and low gradient aortic stenosis.
In terms of coronary stents, the Medtronic TCT agenda features new data on the next-generation drug-filled stent—an investigational stent system that builds upon the platform of continuous sinusoid technology and Core Wire technology, which are currently available on the Medtronic Resolute Integrity and Resolute Onyx drug-eluting stent systems. Most notably, early results following first-in-human implants with the drug-filled stent will be unveiled for the first time. Using breakthrough engineering concepts in device design, preclinical data has shown that the novel, polymer-free drug-filled stent platform enables controlled and sustained drug elution into the arterial wall without a polymer carrier.
For full details of Medtronic’s schedule, click here.