Dive Brief:

  • Medtronic has begun the full U.S. commercial release of its Evolut FX self-expanding transcatheter aortic valve replacement (TAVR) system.
  • The system, which began a limited roll out earlier this year, builds on its predecessor Evolut PRO+ with new features intended to make deployment more stable and predictable.
  • Medtronic is rolling the device out into a market that is beginning to gain access to an updated version of Edwards Lifesciences’ Sapien TAVR device, positioning the two companies to continue going head to head for a multi-billion dollar market.

Dive Insight:

Medtronic’s TAVR sales growth slowed to low single digits in the first quarter of its financial year but the company continues to see the market as a major opportunity, predicting that it will expand from around $5.5 billion today to $10 billion in the next five years. Edwards, being similarly bullish, expects the number of non-invasive heart valve procedures to double by 2028.

Evolut FX is the latest manifestation of Medtronic’s desire to claim a significant slice of the TAVR market. New additions to the device include markers that provide direct visualization of commissural alignment, a redesigned catheter tip for smoother insertion and an updated delivery system with a stability layer intended to make deployment more predictable. Medtronic expects the features to win it market share.

“We expect to be taking strong share and have that be a very strong driver. The physician reception to Evolut FX has been super strong. It’s got easy delivery, great durability and better hemodynamics than anything else out there right now,” Karen Parkhill, chief financial officer at Medtronic, said at an investor event earlier this month.

Medtronic gathered the physician feedback during a limited rollout of Evolut FX earlier this year. The full launch comes more than one year after the Food and Drug Administration approved the device.