New generation heart valve system approved by the US FDA

Release date: 2015-07-09

Medtronic today announced that its new recyclable, self-expanding CoreValve Evolut R transcatheter aortic valve replacement system has been approved by the US Food and Drug Administration (FDA) and is available in the United States.

Medtronic is a medical technology company from the United States that provides lifelong treatment solutions for patients with chronic diseases. Its main products cover cardiovascular diseases, sports disorders, diabetes, gastrointestinal diseases, urinary system diseases, spinal diseases, nervous system diseases and facial features. Surgery and other fields.

According to the China Economic Net reporter, the Evolut R transcatheter aortic valve replacement system is the first and currently recyclable, repositionable heart valve system on the US market, approved for high risk of thoracotomy or Transcatheter aortic valve replacement (TAVR) is performed in patients with severe high-risk severe aortic stenosis. Aortic valve stenosis without treatment can lead to serious heart problems, including heart failure, and even death.

According to Dr. Mathew Williams, Director of Cardiology, Structural Cardiology and Adult Cardiac Surgery, New York University's Langone Medical Center, New York, CoreValve Evolut R is based on the Medtronic CoreValve system, which has been used in more than 60 countries in more than 7 countries. The proven clinical use and successful surgical procedures of the 5,000 patients are the basis for the development of the new generation CoreValve Evolut R.

It is reported that Mathew Williams is also the co-primary researcher of the CoreValve Evolut R registration test. He stressed: "The TAVR procedure has become an effective treatment option for patients with high-risk aortic stenosis who cannot be treated with thoracotomy. Physicians are looking forward to medical advances that will provide patients with better prognostic outcomes. Clinical data have also confirmed that patients have the best prognosis when the heart valve is properly positioned. Therefore, the technological advances of the recyclable Evolut R system make physicians more confident during surgery, an advantage in other TAVI surgical systems. No."

According to the China Economic Net reporter, CoreValve Evolut R transcatheter aortic valve replacement system (23 mm, 26 mm and 29 mm) and CoreValve EnVeo R catheter delivery system have been listed in the US market, and have been in Europe and other Countries and regions that recognize EU CE certification are available. The new generation system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system, where the delivery system is equipped with an InLine sheath that significantly reduces the circumference of the instrument's access to the smallest size on the market (equivalent to a 14Fr circumference). Products less than 1/5 inches, about 4.62 mm). The smaller delivery system circumference provides treatment potential for patients with smaller vessel diameters (minimum to 5.0 mm), and the risk of severe vascular complications can be minimized by the patient's more acceptable transfemoral access.

As the first self-expanding, retrievable transcatheter cardiac main valve system on the US market, the Evolut R approval is the latest in several major milestones that Medtronic has achieved in the TAVR market in recent months. In March 2015, the CoreValve system became the first system in the United States to be approved for surgical aortic valve replacement, and patients with surgical valve damage were treated with a paravalvular valve (VIV). Also at the 2015 American Society of Cardiology Annual Meeting in March of this year, the two-year data release of the highly anticipated CoreValve US key research high-risk patient trial confirmed the use of CoreValve for transcatheter aortic valve replacement compared with surgical aortic valve replacement. Survival benefits are greater.

Source: China Economic Net

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