2015 MedDeviceTracker Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI) Report

Transcatheter aortic valve replacement/implantation (TAVR/TAVI) has revolutionized the treatment of severe aortic stenosis, allowing former inoperative or high risk surgical patients the option of a safer/more convenient procedure to replace the aortic valve. Growing rapidly since its introduction in Europe in 2007 and the US in 2011, over 25,000 procedures were performed in Europe in 2014 and around 17,000 in the US. Older intermediate risk patients have started to be treated, and that trend could well accelerate with completion of pivotal trials in intermediate risk patients versus surgical valve replacement (SAVR), expected this year and next. There are a plethora of novel TAVR valves, with a number that have already reached the market in Europe but not yet the US, and others still further behind in the pipeline.

The MDT Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI) Report covers the following topics:

• Background of aortic stenosis, aortic valve replacement (surgical and transcatheter), and procedural aspects of TAVR.
• Epidemiology of AS and penetration of TAVR in the US and EU.
• Current Market and expectations.
• Comparison of devices, market need, and pipeline.
  • Ideal TAVR characteristics.
  • Trends.
  • Approval timeline.
  • KOL feedback on novel devices.
  • Detailed pipeline.
  • Market overview and forecasted sales (Supplemental Material)

Please also see our accompanying TAVR KOL interview.