Medtronic plc Self-Expanding TAVR Platform Shows Excellent Longer-Term Performance at Five Years in SURTAVI Trial
November 05, 2021 at 11:00 am EDT
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Medtronic plc unveiled five-year clinical data from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, which was presented as a Late Breaking Clinical Trial at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. Data from the trial showed that the hemodynamic (blood flow) benefits of the Medtronic CoreValve? and Evolut? platforms were maintained at five years with an excellent safety profile and stable valve performance in patients with symptomatic, severe aortic stenosis who are at an intermediate risk for open-heart surgery. At five years, rates of all-cause mortality were similar between TAVR with the CoreValve/Evolut platform and surgical aortic valve replacement (SAVR) (30.0% for TAVR versus 28.7% for SAVR; p=0.55), while rates of disabling stroke were also similar (4.1% for TAVR versus 5.8% for SAVR, p = 0.12). The TAVR arm continued to demonstrate durable valve longevity, as evidenced by better mean aortic valve gradients (8.6 mm Hg vs. 11.2 mm Hg; p<0.001) at five years. Additionally, valve thrombosis remained low out to five years for both TAVR and SAVR. In the study, patients considered to be at intermediate risk for open-heart surgery had a risk of mortality of = 3 and < 15% at 30 days following the procedure in combination with other factors. The global, prospective, multi-center, randomized SURTAVI Trial evaluated two early valve generations (CoreValve?, Evolut? R) across a variety of valve sizes in 864 intermediate-risk symptomatic severe aortic stenosis patients. Patients in the TAVR arm were compared to 796 intermediate-risk patients who were randomized to open-heart surgery. The Evolut TAVR platform, which includes the Evolut? R, Evolut? PRO, Evolut? PRO+, and newest-generation Evolut? FX valves, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
