The Edwards SAPIEN Transcatheter Heart Valve for Calcific Aortic Stenosis: A Review of the Valve, Procedure, and Current Literature

Abstract

The Edwards SAPIEN™ transcatheter heart valve (Edwards Lifesciences LLC, Irvine, CA, USA) is approved by the US Food and drug administration for use in the aortic position in patients with severe aortic stenosis who are not surgical candidates. This approval was backed by data from the Placement of AoRTic TraNscathetER Valve (PARTNER) I clinical trial, which showed the valve to be superior to standard medical therapy in high-risk nonoperative patients in cohort B of the trial. Although insertion of the valve is considered to be very safe, stroke, major vascular complications, and conduction abnormalities are the most frequent procedural complications. A dedicated team of physicians trained in structural cardiac interventions, including two interventional cardiologists, an echocardiographer, and a cardiac surgeon, are involved in every case. Improvements in valve design and streamlining of the delivery system, as well as favorable long-term outcomes, will hopefully pave the way for wider patient use in the future.

Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients

“…Usually, LMDMs initiate the contact and offer collaboration to develop a specific product for certain initiatives, under a non-disclosure agreement (NDA). Professor Hijazi has also worked with Edwards Lifesciences [42], as well as smaller companies, including Occlutech (Helsingborg, Sweden), Venus Medtech (Hangzhou, China), NuMED (Hopkinton, NY, USA) and Colibri Heart Valve (Broomfield, CO, USA). The interaction with all these entities was positive.…”

Study on the Effects of Individual Pitot Tube Inlet of a Bladeless Tesla Microturbine using Numerical Analysis

“…It offers flexibility in the design option with low manufacturing cost, reduces vibration and hence improves safety. Although many investigations have been carried out in terms of experimental studies [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] and numerical/analytical studies [11,14,[23][24][25][26][27][28], the result is still far from Tesla's achievement. This is mostly due to the losses issue that needs to be accounted for designing and testing the turbine.…”