ARTICLE SUMMARY:
Medtronic and Edwards are expanding into the much smaller transcatheter pulmonary valve replacement market. Excerpted from our recent feature article “A Passion Project”: Edwards and Medtronic Persevere Against TPVR Challenges.”
Transcatheter technology has transformed heart valve repair and replacement over the last 15 years, first with the advent of transcatheter aortic valve replacement (TAVR), and more recently with advances in transcatheter tools to repair or replace the mitral and tricuspid valves. Patients with defective pulmonary valves also need an alternative to open-heart surgery, but TPVR—transcatheter replacement of the pulmonary valve (also referred to as the pulmonic valve)—has not received nearly as much investment, innovation, or attention.
TPVR procedures are relatively rare. For example, a recent review of the American College of Cardiology’s IMPACT Registry found just 4,513 TPVR procedures with balloon-expandable valves were performed in the US between April 2016 and March 2021—43% with Edwards Lifesciences’ Sapien system and 57% with Medtronic’s Melody system (see sidebar at end of story, “Medtronic Pioneered TPVR; Edwards Followed”).
Medtronic claims to be the TPVR market leader and is on pace to treat nearly 6,000 patients worldwide with TPVR in 2025. To date, over 3,100 patients have been treated with Edwards’ Harmony TPVR and more than 23,000 have been treated with the original Melody system over the last two decades. Edwards does not publish exact TPVR figures, but it says its annual TPVR sales are in the “thousands.”
Thousands may sound like a lot, but for comparison, the number of TAVRs performed annually in the US surpassed 250,000 about five years ago and the TAVR market opportunity is expected to be worth more than $10 billion annually within the next five years.
In addition to being relatively rare, “[TPVR] patients are incredibly complicated,” says Larry Wood, former group president of Edwards’ transcatheter aortic valve replacement and surgical structural heart businesses. Every patient must be carefully screened to determine if they are suitable for TPVR and because these are pediatric patients not covered by Medicare, reimbursement is not always reliable.
In some regions, the same interventionalists performing TAVR might also perform TPVR, but congenital heart disease and structural heart disease are largely separate specialties, requiring a separate sales and service approach. Edwards’ TPVR customers are usually based in children’s hospitals, for example.
Even though the market opportunity is too small to even appear on a sales and earnings report, Edwards sees TPVR as part of its company’s mission, supported by senior leadership.
“It's a tremendous patient need, [but] if we were just doing this for money motives it would not be a good business,” Wood says.
Medtronic is also invested in TPVR, not only to help those patients directly, but also to advance structural heart technology in general, according to Jorie Soskin, the vice president and general manager of Medtronic’s structural heart business.
“[TPVR] not only provides solutions for [those patients] and those physicians, but it also teaches us other things and capabilities that are utilized in other therapies,” Soskin tells MedTech Strategist. “We don't necessarily think about it relative to the size of the market. It's about how can we serve a unique population with unique technologies and the opportunity to take that learning and apply it to TAVR, mitral and tricuspid valves—that is foundational.”