ESC 2018 preview – A possible boost for Abbott, and balloons go up against stents

In a quiet year for medical devices a couple of studies are still worth watching.

Highly unusually, none of the hotline presentations at this year’s annual meeting of the European Society of Cardiology, to be held in Munich on August 25-29, concerns trials sponsored by medtech companies. But two academic studies might affect device makers’ fortunes.

Abbott’s MitraClip was CE-marked 10 years ago, and approved in the US in 2013 to repair the mitral valve in severely symptomatic patients with chronic severe primary mitral regurgitation (MR) who are at high risk for surgery.

The Mitra-FR trial, results from which will be presented on August 27, is assessing the device in the treatment of patients with severe secondary MR. These patients have functional MR with dilated ventricles mainly in ischaemic or idiopathic cardiomyopathy, as opposed to the primary population whose valves have organic lesions. 

The functional MR population is much broader so, if Mitra-FR can show that MitraClip treats these patients better than standard medical care, uptake of the device could get a boost. Global sales of MitraClip are forecast to hit $1bn in 2024.

Global sales forecasts for Abbott’s MitraClip ($m)

2017

2018e

2019e

2020e

2021e

2022e

2023e

2024e

CAGR

473

532

621

706

781

879

978

1,078

+12%

Source: EvaluateMedTech.

The Basket-Small 2 study, data from which will be presented on August 28, pits two different means of widening small blood vessels against each other: drug-eluting stents versus drug-coated balloons. The actual devices in the trial are B. Braun Melsungen’s SeQuent Please balloon and either Boston Scientific’s paclitaxel-eluting Taxus Element or Abbott’s everolimus-eluting Xience stents, but the results will be generalised to all similar devices.

Selected drug-coated balloons

Device 

Company

EU approval (CE Mark)

US approval

Lutonix 

Becton Dickinson

Jun 28, 2011

Oct 9, 2014

IN.PACT Admiral

Medtronic

May 19, 2009

Dec 29, 2014

Stellarex

Philips 

Dec 31, 2014

Jul 26, 2017

SeQuent Please

B. Braun Melsungen

Mar 30, 2009

-

Ranger

Boston Scientific

Jul 14, 2014

-

Source: EvaluateMedTech and company communications.

SeQuent Please itself, for example, is not yet approved in the US. Only three balloons are, as summarised in the table above. Playing both sides of the stent/balloon divide, Boston Scientific is developing its own drug-coated balloon, Ranger.

Trial ID Data due
Mitra-FR NCT01920698 Monday August 27
Basket-Small 2 NCT01574534 Sunday August 28

Follow Elizabeth Cairns and Madeleine Armstrong on @LizVantage and @ByMadeleineA for live tweets from the ESC conference.

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