The Wider View: Eluvia hogged TCT limelight, but is Boston Scientific’s Lotus set to blossom again?

There was much media fanfare around Boston Scientific’s Eluvia drug-eluting vascular stent this week – first, for beating Cook’s Zilver PTX stent in a head-to-head trial then getting US FDA approval just two days after the trial results were presented at TCT 2018. On the other hand, Lotus, Boston Scientific’s transcatheter aortic valve replacement (TAVR) system which was the subject of a global recall last year, had a more muted reception at the meeting in spite of showing some solid long-term data. But Lotus is “on the upswing” again, the company assured investors, and the product is now in the final steps of making its market comeback in the first quarter next year.   

What happened

Boston Scientific’s Lotus TAVR system was a key focus of discussion during the company’s update of its cardiovascular business at the Transcatheter Cardiovascular Therapeutics (TCT 2018) meeting on September 24.

In February 2017, Boston Scientific initiated a global recall of all its Lotus systems – including the newer generation Lotus Edge which had only been CE marked for European commercialisation a few months earlier – following reports of the premature release of a pin connecting the Lotus valve to the delivery system. At that time the company had anticipated bringing the product back to market in Europe and other regions in the fourth quarter that year, while filing the US premarket approval for Lotus Edge around the same time with the view of a US launch in mid-2018.   

But these plans had to be pushed back, the company announced in November 2017, as it dealt with changes to the manufacturing process and design specifications of Lotus Edge following the recall, and in February this year, when reporting its Q4 2017 results, the company set a goal of 2019 for the launch of Lotus in the US and Europe.

At Boston Scientific’s cardiovascular business update at TCT 2018, Kevin Ballinger, president of the company’s interventional cardiology unit, provided some positive news – "finally," he remarked – on Lotus and said the product was “on the upswing.” Among other things, he reconfirmed that the third and final technical module of the US premarket approval application for Lotus Edge had been submitted to the FDA on August 15 and is under review. He also narrowed down the timeline for Lotus’ much anticipated European comeback to H1 2019, and pending FDA approval, a mid-2019 US launch.

The wider view

Kevin Bellinger accurately summed up the sentiment around this TAVR product when he made the quip, “the rollercoaster called Lotus.” The vibe was generally positive among investors when Bellinger fleshed out the firm’s upcoming plans, not only for the commercialisation of Lotus in Europe and the US, but also how it would sit alongside Acurate neo, the other TAVR product that Boston Scientific had gained through its acquisition of French company Symetis in May last year.

In preparation for Lotus’ comeback, Boston Scientific is continuing to build clinical evidence to further back the performance of the technology. Bellinger told investors that the company was currently enrolling for the REPRISE III Nested Registry. This is a 50-patient trial to confirm the acute performance of Lotus Edge, which, Bellinger said, should be fully enrolled during October.

Lotus is already proving itself at TCT 2018 where solid longer-term data were presented, albeit to a much more muted reception compared to Boston Scientific’s Eluvia drug-eluting vascular stent. The data presented at TCT included: five-year safety and clinical outcomes of Lotus in the REPRISE II study, which showed that the TAVR system demonstrated good hemodynamic results, minimal paravalvular leak, significant and sustained improvement in heart function and a favourable safety profile; and two-year follow-up data from REPRISE III, where Lotus was pitted against Medtronic’s CoreValve system and showed patients treated with Boston Scientific’s system had fewer disabling strokes at two years, with a lower rate of moderate-to-greater paravalvular leak, compared to CoreValve.

Data from the REPRISE III Nested Registry could only be a further boost for Lotus and help assuage any clinical concerns that might linger following the recall.

The company also plans to file an IDE with the FDA by the end of this year for REPRISE IV, an 810-patient single-arm trial with a bicuspid sub-study.

So once it does hit the markets, how does Boston Scientific plan to position Lotus alongside Accurate neo? While Lotus has been off the market for a good part of a year, Boston Scientific has been building up Acurate neo’s presence in Europe (the device is only CE marked). According to Bellinger, Acurate neo is the fastest growing TAVR valve in Europe, with a growth rate of more than 40 percent this year to date. Additionally, since Boston Scientific acquired Symetis, more than 130 new accounts for Accurate neo has been opened, enabling Boston to gain around 20 percent market share through its launched accounts.

Bellinger acknowledged that Accurate neo was doing very well in Europe, and in terms of pricing, the margins are better for this product than for Lotus. But he added that there are some “very passionate” Lotus users in that market who are anxious to try the TAVR system again. With the European market being notoriously fragmented with wide variations from one country to another, the company will take a rifle approach in terms of where it takes Lotus, noted Bellinger. “In general, the European relaunch of Lotus will be a precision strike, versus a wide launch,” he said.

The US on the other hand is not as exposed to TAVR as Europe, and while Lotus will likely be first to market there and Accurate neo might follow around 18 months later, all is to play for. How this pans out, of course, will depend on Lotus getting that all-important FDA approval first.