Feature | Heart Valve Technology | July 10, 2017

FDA Expands CoreValve TAVR Valve Use for Intermediate Risk Patients

Self-expanding TAVI device can now be used in intermediate risk surgical patients with symptomatic, severe aortic stenosis 

Medtronic's CoreValve Evolut R gained FDA approval for intermediate risk patients

An illustration of the self-expanding CoreValve Evolut R TAVR valve half deployed in the aortic root.

July 10, 2017 — The U.S. Food and Drug Administration (FDA) has cleared an additional indication to expand the use Medtronic's self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to patients deemed to be at intermediate risk for open-heart surgery. 

Patients who are at intermediate risk for open-heart surgery have a risk of mortality of less than or equal to 3 percent at 30 days following the procedure. The risk assessment is determined by a heart team (including an interventional cardiologist and cardiac surgeon), in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as co-morbidities, frailty, prior surgical intervention and disabilities.
 
"As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays," said Michael Reardon, M.D., professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center. "It's important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study."

Watch a video interview with Reardon at the American College of cardiology (ACC) 2017 meeting where he presented the SURTAVI results.

The global SURTAVI Trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14 percent for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.

Read the article on SURTAVI from ACC.17 “TAVR Stands Equal to Surgical Valve Replacement.”

The CoreValve Evolut platform consists of the CoreValve, CoreValve Evolut R and the recently FDA-approved CoreValve Evolut PRO systems, which are available for use in the United States with severe aortic stenosis patients at an intermediate surgical risk or greater. The CoreValve Evolut PRO System is currently not approved for commercial use outside of the United States.
 
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

The Edward Lifesciences Sapien valve, the only other TAVR valve currently cleared for use in The U.S., gained the intermediate risk indication last August. Read the article “FDA Expands Sapien TAVR Valve Indication to Intermediate-Risk Patients.”

Watch a VIDEO interview with Reardon at TCT 2016 on the state of TAVR.

Last year at ACC 2016, the biggest news was that the Sapien 3 valve out performed surgery in intermediate risk surgical patients. Read more about that trial and others

Related Content

Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Arterial Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet (S-DAPT) after DES stent implantation
News | Antiplatelet and Anticoagulation Therapies| July 12, 2017
June 12, 2017 — Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet ther
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Patient Race, Gender Both Important in Predicting Heart Attack Symptoms in the ER
News | Cath Lab| July 07, 2017
Researchers at the George Washington University (GW) found that certain symptoms are more and less predictive of...
ACCESS PTS Study Demonstrates Efficacy of EKOS Therapy for Post-Thrombotic Syndrome
News | Deep Vein Thrombosis| July 07, 2017
BTG plc recently highlighted the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th...
Heartflow FFR-CT can noninvasively assess the hemodynamic impact of coronary lesions to avoid the need for an invasive angiogram.

HeartFlow FFR-CT can noninvasively assess the hemodynamic impact of coronary lesions to avoid the need for an invasive angiogram.

Technology | CT Angiography (CTA)| July 06, 2017
July 6, 2017 — GE Healthcare and HeartFlow Inc.
Overlay Init