Renal denervation is not worth the candle. Such is the conclusion of Covidien, which has decided to pull its OneShot system from the market in the EU two years after it was approved.
Covidien says its decision was based on weak sales, but the shock US pivotal trial miss suffered by Medtronic’s EU market-leading Symplicity system, which looks likely to prompt cessation of its development, will surely have contributed to the rationale. Covidien’s move may be wise as far as the company itself is concerned. But it is too soon to write off the technology as a whole; while the Symplicity failure came as a shock, it is still more than possible for denervation to find a niche in drug-resistant hypertension.
Bought and paid for
At least Covidien can console itself with the thought that, of the three companies that bought their way into the renal denervation market through acquisitions, it paid the least (see table). Its deal for Maya Medical saw it pay just $60m up front, with up to $170m more dependent on regulatory and sales targets, few if any of which will have been achieved.
Medtronic’s purchase of Ardian, which gave it Symplicity, was considered excessively generous even at the time. With the technology now likely to be shelved, it looks downright profligate (Failure of Medtronic’s Symplicity trial exacerbates concerns over renal denervation, January 9, 2014).
The most recent company to join the rush, Boston Scientific, has also felt the shockwaves from the Symplicity failure and is pausing to consider the future of its denervation technology, for which it acquired Vessix Vascular (Boston Scientific gatecrashes renal denervation market with Vessix buy, November 9, 2012). The company has said it is waiting for the full results of Medtronic’s study to assess whether the miss was due to trial design or a problem common to all denervation systems before it decides whether to push on with a pivotal US trial.
The data are expected to come out at the American College of Cardiology meeting in Washington, DC in late March.
Covidien can now save itself the expense of completing a European clinical trial, Rapid II, which was intended to test OneShot against antihypertensive drugs in 325 patients. It will also be able to escape the expense of a US study, though shuttering the programme will cost $20-25m after tax, the group says.
Approval still possible
So with one company out, another almost certainly out and a third waiting for more information, renal denervation is a sorry sight. But all is not lost. The Medtronic trial was unusually rigorous by device standards and a device might gain US approval by showing a modest effect on blood pressure.
The market opportunity will be smaller than had been expected – at the point when Boston bought Vessix, Jefferies analysts projected that the renal denervation market would be worth nearly $3bn by 2020 – but drug-resistant hypertension is a problem that needs a solution. The full Symplicity results will determine whether any of Medtronic’s rivals decide to hold faith with this still potentially useful technology.
|Company||Device name||CE mark date||Strategy|
|Medtronic||Symplicity||April 1, 2010||Company acquisition: Ardian,
November 2010, $800m up front
|Covidien||OneShot||February 1, 2012||Company acquisition: Maya Medical,
May 2012, $60m up front
|St. Jude Medical||EnligHTN||May 15, 2012||Organic|
|St. Jude Medical||EnligHTN (second generation)||August 29, 2013||Organic|
|ReCor Medical||Paradise||January 24, 2013||Organic|
|Terumo||Iberis||April 8, 2013||Organic|
|Boston Scientific||Vessix Vascular V2||May 22, 2013||Company acquisition: Vessix Vascular,
November 2012, $125m up front
|Medtronic||Smurf||Had been expected 2014||Organic|
|Johnson & Johnson||Renlane||-||Organic|
Data sourced to EvaluateMedTech