It might feel like a transcatheter alphabet soup out there with all of the valve interventions that have come out in the last few years, but Cardiac Wire is here to help make sense of it all.
Currently, all four heart valves have options for transcatheter replacement, though the availability and prevalence of these procedures vary, so we’ll break them down by valve, then intervention.
The Aortic Valve: Transcatheter Aortic Valve Replacement (TAVR or TAVI), is the most established and commonly performed procedure among the valve interventions.
- It’s used primarily for severe aortic stenosis in high-risk patients (recently approved for younger, lower risk patients).
- Leading devices include Edwards’ Sapien 3 series (55-60% share in the U.S.) and Medtronic’s Evolut series (30-35% share), followed by Abbott’s Navitor/Portico.
- For aortic regurgitation, the FDA recently approved JenaValve’s Trilogy system.
- TAVR is by far the most established market, worth about $7B and making up ~80% of all transcatheter revenue.
The Mitral Valve: Transcatheter Mitral Valve Replacement and/or Repair (TMVR) is currently positioned as an evolving alternative to open-heart surgery.
- It’s used for severe mitral regurgitation or stenosis.
- Currently, TMVR is frequently performed as a valve-in-valve procedure, replacing previously failed surgical MVRs.
- The TMVR market is worth $2B to $3B and is currently dominated by repair procedures ($1.6B).
- The FDA approved MV replacements are Edwards’ Sapien M3 and Abbott’s Tendyne.
- The approved repairs are Abbott’s MitraClip, Edwards’ PASCAL Precision, and HighLife’s HighLife TMVR.
The Pulmonic Valve: Transcatheter Pulmonary Valve Replacement (TPVR) is a routine procedure, particularly in patients with congenital heart disease.
- Often used for patients with Tetralogy of Fallot or those who have failed previous surgical repairs.
- The pulmonic market is considered niche at only $300M-500M in value.
- Medtronic’s Melody & Harmony valves have an estimated ~70% market share, with Edwards’ Sapien 3 Pulmonic taking up the rest.
The Tricuspid Valve: Transcatheter Tricuspid Valve Replacement (TTVR) is the most recent of the four valves to hit the market due to its anatomical complexity.
- It’s currently used to specifically target severe tricuspid regurgitation.
- Edwards’ Evoque system is still the only to receive FDA approval.
- The TTVR market is currently valued under $200M.
However, there are several FDA approved TR repairs –
- Abbott’s TriClip, Edwards’ PASCAL, and P&F Products & Features’ TricValve.
The Takeaway
While it may be hard to keep track of the growing number of transcatheter valve interventions in the U.S., one thing is for certain, innovations are pushing us further into the realm of these types of procedures, regardless of market size.
