With almost no sales and marketing operation Jarvik Heart has quietly managed to snare 25% share of the heart pump market in France and Italy, and 40% in Japan. Considering that its competitors include Medtronic and Abbott, this is impressive. The question is whether it can replicate the feat in the US.
The company is starting pivotal US trials for an entirely new, much smaller left ventricular assist device (LVAD) designed for use in children awaiting a heart transplant. “Ours is the only one that is going to be approved for infants,” says Peter Hinchliffe, Jarvik Heart’s president. He explains that, should it gain FDA approval in this setting, the company will expand its use into adult patients. This technology could be a major success in heart failure – either for Jarvik itself or for any company that acquires it.
An acquisition is clearly the best way to expand sales of Jarvik’s devices. The private group – it is owned by the artificial heart developer Robert Jarvik – is expecting sales of around $15m this year and while its manufacturing base in downtown Manhattan is coping well at the moment it will not be sufficient for commercial demand should widespread use be permitted.
The Jarvik 2000 LVAD is CE marked and has been on the market in Europe since 2005; around 130 are implanted each year. It is the smallest commercial-stage pump in the world, and unlike the other offerings it can be implanted without cracking the chest. But the new device the company is working on is smaller still.
This device is called the Jarvik 15mm LVAD. Mr Hinchliffe says it is the size of an AA battery and is suitable for patients who weigh 5kg or more – roughly those aged around two months and up. That said, the enrolment criteria for the pivotal Pumpkin trial specifies patients who weigh 8-20kg.
Pumpkin will enrol 88 patients, half of whom will be treated with a Jarvik 15mm and half the only assist system for children available in the US: Berlin Heart’s Excor. But this is not an implanted device, and Excor patients cannot leave the hospital. Many cannot leave their bed.
The study’s endpoints concern adverse event rates and survival at six months. “We’ve had people live nine and a half years on the Jarvik 2000,” Mr Hinchliffe says, “It’s the identical design, it’s just downsized. We feel very confident that this pump will perform as well as its larger brother.”
The Jarvik 2000 and the smaller Jarvik 15mm
One of the most common adverse events associated with LVADs is infection, and here Mr Hinchliffe says the larger, marketed Jarvik 2000 has an advantage over other devices on the market.
All other implanted LVADs have a drive line – a power supply – that exits the patient’s skin at the abdomen. Infection rates in these drive lines are around 30% or 40%, Mr Hinchliffe says, and they have a deleterious effect on quality of life, with patients unable to bathe or swim as they cannot immerse themselves above the level of the drive line.
The power supply to the Jarvik 2000 does not exit via the abdomen. Instead the wires are fed up through the neck to a small titanium post that is screwed to the skull and comes out through the skin behind the patient’s ear.
“That has been proven, in cochlear implants, to have extremely low infection rates, and because the post is attached to the skull there’s very little movement that could tear tissue,” Mr Hinchliffe says. The infection rate with this drive line is around 2%, he says.
The 2000 is in a pivotal US trial as a permanent implant, known as destination therapy. The 350-patient trial started in 2013 but so far only 50 or 60 patients have been enrolled, and data will not be released until 2018, so the Jarvik 2000 will likely be overtaken by the 15mm thanks to shorter follow-up in the paediatric study.
Mr Hinchliffe says that the technological advantages of the 2000 explain how it has come to occupy such a big slice of the market. Though Medtronic and Abbott are its most powerful competitors they are not the only ones – Berlin Heart and ReliantHeart have CE marked LVADs too (ReliantHeart relies on tech to lure buyer, August 17, 2016). The devices do not compete on cost, he says, with the Jarvik 2000 being sold in Europe at much the same price level as the others.
But growing sales in Europe and expanding onto the US will be tricky without the kind of investment Jarvik cannot afford.
The best chance for Jarvik Heart to grow may be to become part of a bigger company that has greater sales and marketing muscle. It is possible that Boston Scientific or one of the large companies in heart failure might be interested in Jarvik Heart's technology.
Doubtless potential acquirers would want to look at pivotal data – or even wait until one or both devices gains US approval – before jumping.
|Pivotal US trial of Jarvik 15mm in 88 paediatric patients (Pumpkin)||NCT02954497|
|Pivotal US trial of Jarvik 2000 in 350 adult patients||NCT01627821|