It’s not your father’s transcatheter aortic valve implant anymore.
Next year and the year after, the competitive landscape for TAVI will explode, with as many as 12 competing devices on the market here and across the pond.
And that competition will be fierce. As TAVI celebrates its 10th birthday,at least 1 analyst is predicting a 20%+ compound annual growth rate for the market, which she says could potentially double by 2015.
Medtronic‘s (NYSE:MDT) CoreValve TAVI was first to market, hitting European shelves in 2007. Edwards Lifesciences (NYSE:EW) wasn’t far behind, putting its Sapien TAVI in the EuroZone a few months later and beating CoreValve to the U.S. market late last year.
But a spate of newer devices, some from the 2 big boys on the block, some from fellow medical device giants Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ), and some from smaller, less well-known rivals, are in the pipeline.
Despite that, Danielle Antalffy, an analyst for the Leerink Swann healthcare investment bank, believes Edwards has the edge as it readies the 2nd- and 3rd-generation models of its Sapien valve and its 4th-generation Centera, which Antalffy sees entering clinical trials for CE Mark approval "before year-end."
Edwards is "best-positioned to benefit from strong TAVI market growth despite increasing EU competition" because "U.S. competition isn’t likely before the late 2014/2015 timeframe," she wrote in a note to investors.
"To us, EW seems most likely to maintain EU market share despite increasing competition, given a significantly lower rate of permanent pacemaker and a market-leading surgical valve business. In 2013, we model basically stable EW EU market share with MDT’s CoreValve market share declining to 41% from 48% expected in 2012," Antalffy wrote.
St. Jude is next in line with its Portico TAVI device, with a CE Mark expected by the end of the year and a U.S. investigational device exemption trial slated to start in 2014.
Boston Scientific is developing its Lotus valve and expects to launch a CE Mark trial this week, according to Antalffy. Then there’s Direct Flow Medical and its eponymous device, expected to launch a CE Mark trial during the 1st quarter of 2013 and a U.S. IDE trial later that year.
Other players include JenaValve and its self-named device and Symetis’ Acurate valve, both of which won CE Mark approval in September 2011.
But wider adoption for all TAVI devices depends on what’s become the Holy Grail of medtech: Reimbursement. Favorable cost-effectiveness data contrasting TAVI with open heart surgery will be necessary to see widespread reimbursement decisions for the procedure, according to a surgeon Antalffy spoke with at the PCR London Valves conference this week. Other adoption factors include reduced 30-day mortality and stroke rates, lower paravalvular leak rates and improved durability, according to the physician.
"Several sessions focused on cost-effectiveness data – which are clear in transfemoral patients but less convincing in transapical patients to-date – and the importance of reimbursement in potentially driving wider adoption," Antalffy wrote. "As the transcatheter aortic valve market matures and experience increases, cost-effectiveness data in both the TF and TA arms, as well as in lower-risk patient populations, could become even more compelling."
Here’s a look at the competitive landscape, courtesy of heartwire.
| Company | Valve (sizes; delivery) | Status |
| Boston Scientific | Lotus (TF) | Reprise trial |
| Direct Flow Medical | Direct Flow (TF) | Discover trial |
| Edwards Lifesciences | Sapien XT (23mm, 26mm, 29mm; TF, TA) | Source XT registry |
| Edwards Lifesciences | Sapien 3 (26mm, 20mm, 23mm, 29mm; TF) | CE Mark trial begun |
| Edwards Lifesciences | Centera (23mm, 26mm, possibly 29mm; TF or subclavian) | CE Mark trial expected late 2012 |
| JenaValve | JenaValve (23mm, 25mm, 27mm; TA) | CE Mark 2011 |
| JenaValve | JenaValve (TF) | Unknown |
| Medtronic | Engager/Ventnor (23mm, 26mm; TA) | CE Mark trial underway |
| Medtronic | CoreValve Evolut (23mm; TF) | Registry |
| St. Jude Medical | Portico (23mm; TF) | CE Mark trial underway; IDE trial expected 2013 |
| Symetis | Acurate (TA) | CE Mark 2011 |
| Symetis | Acurate (TF) | CE Mark submission expected 2013 |
