CoreValve^™ and Evolut^™ TAVR Systems

KEY POINTS

• Aortic stenosis (AS) is one of the most common and serious valve disease problems. Chest pain and shortness of breath are typically the reasons adults seek medical care for AS. An estimated 300,000 people worldwide annually are diagnosed with severe symptomatic aortic stenosis. Patients with AS and heart failure symptoms have an average life expectancy of two years.
• The CoreValve and next generation Evolut systems are Transcatheter Aortic Valve Replacement (TAVR) devices used in a procedure that is less invasive than traditional open-heart surgery. It provides an important treatment option for certain intermediate and greater surgical risk patients who are poorer candidates for open-heart surgery.
• CoreValve and Evolut valves have been evaluated in more than a dozen clinical trials. The studies provide consistent data establishing the safety and efficacy of the CoreValve system, and several of these studies confirm its durability out to five years.

Overview

1. Aortic Stenosis is a Common and Serious Disease
   
   

   Aortic stenosis, a narrowing of the aortic valve opening, is one of the most common and serious valve disease problems. The narrowing reduces blood flow from the heart into the main artery to the body, the aorta.¹ When this happens, the heart is forced to work harder to pump blood to the body. Over time, the extra work can weaken the heart muscle. Left untreated, severe AS is a serious, life-threatening condition that can lead to heart failure and increased risk for sudden cardiac death.² Worldwide, approximately 300,000 people annually are diagnosed with symptomatic, severe aortic stenosis, and approximately one-third of those patients are at intermediate or higher risk for open heart surgery.³ Patients with AS and heart failure symptoms have an average life expectancy of two years.

2. Medtronic’s CoreValve System
   
   

   The CoreValve system is a Transcatheter Aortic Valve Replacement (TAVR) device used in a procedure that is less invasive than open-heart surgery. It provides an important treatment option for patients who are poorer candidates for traditional open-heart valve replacement. With CoreValve and Evolut TAVR, a small incision is made in the leg, neck or chest and a thin, flexible tube (catheter) holding the new aortic heart valve is guided to the heart by the physician using imaging and a delivery system and then positioned by the physician within the diseased aortic valve. After positioning the bioprosthetic valve, the physician deploys the valve and it expands within and replaces the function of the diseased native valve. Benefits of CoreValve and Evolut TAVR treatment include improved blood flow and reduced symptoms. Patients often feel relief of symptoms immediately after the procedure.

3. The CoreValve System Has an Excellent Safety Profile and is Effective for Treatment of Symptomatic Severe Aortic Stenosis
   
   

   The safety and efficacy of Medtronic’s CoreValve system has been evaluated in more than a dozen clinical trials, including Medtronic’s CoreValve U.S. Pivotal Trial (1,389 subjects followed for five years) and the SURTAVI trial (1,660 subjects followed for two years with a plan for ten-year follow-up). These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years.⁴ Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery.