In the Wake of the “Implant Files”: Unheard Ideas to Make Device-Based Therapies safer and always more Innovative| Biomed Grid

The invention of implantable devices has revolutionized how doctors treat their patients. The case of faulty aortic valve replacement illustrates the spectacular progress which has been achieved. The first prosthetic aortic valve was implanted in 1952 by Dr. Hufnagel. The valve was made of a rigid cylindrical bulb chamber containing an acrylic ball. The prosthetic valve, which was placed in the descending aorta during a high-risk surgical procedure, improved the conditions of hundreds of patients in the fifties, though it offered poor hemodynamics and patients could hear the valve's prosthetic ball bouncing around in the chamber [1]. Today's transcatheter aortic valve replacement (TAVR) prostheses use biological tissue to form three valve leaflets, thereby imitating the native valve and optimizing treatment outcome. The TAVR valves are commonly implanted through a minimally invasive femoral artery access in less than an hour. In the last decade, this revolutionary technology has been used to treat around 400,000 patients worldwide [2]. The medical device industry continues to invest in developing better solutions for patients thus transforming and improving treatments. Earlier this year, the US Food and Drug Administration (FDA) showed a promising 9% annual growth in the number of novel device approvals during the period 2009-2018 [3].