Boston Scientific’s plan to keep the rhythm going

The annual meeting of the Heart Rhythm Society last week was a bit up and down for Boston Scientific – perhaps mostly down. Aside from the findings of the Cabana study suggesting that cardiac ablation was no better than medication for atrial fibrillation patients, data on Boston’s heart implant Watchman pointed to a risk of thrombosis and stroke.

A welcome bright spot was provided by results backing new software used in the company’s subcutaneous implantable cardioverter-defibrillator that could raise sales. “It just takes away what was one of the barriers and concerns that people had in trying to decide between using a transvenous device or subcutaneous device,” says Ken Stein, chief medical officer of Boston’s rhythm management unit.

The heart rhythm management sector, which comprises devices that regulate a patient’s heartbeat such as pacemakers and implanted defibrillators, is dominated by three big groups, none of whose sales are moving much. Boston is the third placed of these, with cardiac rhythm sales of just over $2bn forecast in 2024.

Hearts and minds

The company recently moved to unite the heart rhythm unit with its neuromodulation operations in search of efficiency savings that could help it compete; the segment will be renamed Rhythm and Neuro.

“There are a lot of synergies between active implantable devices,” Mr Stein says. “Whether it’s neuromodulation or traditional cardiac rhythm management we’re basically talking about battery-powered pulse generators with computer systems on board, hooked up to leads or wires that are delivering electrical impulses.”

This technological similarity means the company can save cash by integrating R&D and manufacturing, regardless of whether the end product is to deliver shocks to the heart or the brain.

The S-ICD was launched in 2012 as a crucial new technology to help drive sales growth at Boston, which was in the doldrums at the time (Boston Scientific remakes itself to face the future, October 22, 2012). The subcutaneously implanted device is now renamed Emblem, and is used in patients who cannot be treated with more invasive traditional pacing devices, which require leads to be threaded through the patient’s vasculature to the heart.

The risk of inappropriate shocks has been one of the barriers to physicians adopting the first-generation S-ICD. But this could now change thanks to an analysis of a blinded trial, Latitude, of an algorithm incorporated into Emblem.

“The data show this new algorithm, which is called Smart Pass, is associated with a marked reduction in inappropriate shocks from the device, to the point now where the device is comparable to a contemporary transvenous ICD,” Mr Stein says.

The rate of inappropriate shocks – those given even though they were not required by ventricular tachycardia or fibrillation – fell from 9.7% without the Smart Pass filter to 4.3% with it enabled – a significant difference. The number of inappropriate shocks per patient averaged 28 per 100 patient-years without the algorithm, versus 7 with it switched on; again this was significant.

The data ought to permit Boston to reach into a much larger population with Emblem.

“The biggest opportunity is in what we sometimes call that broad middle-ground population,” says Mr Stein. These are patients who do not need cardiac resynchronisation therapy – they do not have bradycardia or tachycardia – but who have a primary prevention indication for a defibrillator; they are at risk of sudden cardiac arrest.

Primary prevention patients are the bulk of ICD implants in the US today. “It’s the best opportunity to improve patient outcomes while avoiding most of the disadvantages associated with transvenous leads.” Boston is seeing growing adoption of the S-ICD for this group of patients, Mr Stein says, and is running a large trial called Untouched looking at outcomes with the S-ICD in this primary prevention population.

Dishing the DRT

The company must hope that the sales uplift for Emblem can compensate for any drift in revenues from Watchman, after disappointing data reported at the HRS meeting. The product blocks a pouch in the heart called the left atrial appendage in which blood can pool and form clots, thereby guarding against stroke in patients with atrial fibrillation. It reached the US in 2015 after a troubled gestation.

The HRS data showed that device-related thrombosis (DRT) was seen in 3.74% of Watchman-treated patients, and further, that those who had DRT were more than three times as likely to have stroke or systemic embolism than patients without.

Rates of stroke or systemic embolism with and without DRT were 7.46 and 1.78 per 100 patient years, a significant difference. There was no significant difference in mortality between patients with DRT and those without, however.

The investigators insisted that Watchman was still a viable treatment, saying future therapy was simply a matter of monitoring patients carefully and prescribing longer-term anticoagulation. A new version, Watchman Flex, is in the clinic and might carry a lower risk of DRT owing to its smaller size.

At least the Cabana results, though probably bad news for Boston, were equally poor for its competitors (Ablation groups scramble to cope with Cabana, May 11, 2018).

Bought in

On another strategic point, it is worth noting that neither the S-ICD nor Watchman was developed in-house. The former came from Cameron Health, which Boston bought in a deal worth up to $1.3bn in 2012, and the latter from Atritech, bought for $375m a year earlier.

Boston has long been acquisitive, particularly in its core cardiovascular area – it has spent the best part of $5bn buying 17 cardiology companies or business units over the past decade. Mr Stein declined to comment on Boston’s future plans for making acquisitions, but future tuck-in deals are almost assured.

As for any major M&A activity, this might depend on whether the HRS data have any marked effect on revenues from Boston’s heart rhythm – or as it must now be called, Rhythm and Neuro – segment.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizVantage on Twitter