ESC 2016 – Biotronik is small but steadfast

The private German group Biotronik is a small fish in a big pond: it is the fourth-largest company in cardiac rhythm management, and is up against the likes of Medtronic, Boston Scientific and St. Jude Medical, many times its size.

“We’re not big. So what?” says Manuel Ortega, senior vice-president at Biotronik. “We’re big enough to be a global competitor. Our share of the market is substantial enough that we have enough critical mass to develop the right products.” But St. Jude is soon to be taken over by Abbott. One of the bigger fish in Biotronik’s pond is about to get larger still.

Less for more

That Biotronik has lasted this long without being bought is a result of the fact that its board does not have shareholders to please, but also is a testament to its product offering.

Part of the rationale behind the large cardiovascular mergers, from Medtronic-Covidien to the Abbott-St. Jude deal, was to create a company that could meet a wider range of a hospital’s needs, selling everything from pacemakers to ventricular assist devices to ablation catheters.

“There is a substantial number of buyers who like to get more for less money,” Mr Ortega acknowledges. “With the bundling approach, the bigger the portfolio the more chance you have to do it.”

Biotronik believes that there are even more customers who are willing to go to a smaller company if they are offering the best devices. “If it’s about discounting and buying more boxes, other people have more chance to get that, but we’re doing quite well with our strategy, which is to create value for the provider.”

Implantable cardioverter defibrillator makers
Global sales ($m)
Company 2015 2022 CAGR
Medtronic 1,539 1,605 +1%
Boston Scientific 1,313 1,433 +1%
St. Jude Medical* 743 765 +0%
Biotronik 292 339 +2%
*Soon to be taken over by Abbott Laboratories. Source: EvaluateMedTech

At the ESC meeting in Rome today Biotronik presented a meta-analysis of three studies, in a total of 2,405 patients, of its remote monitoring system for implantable cardioverter-defibrillators (ICDs). The data showed a 38% reduced risk for all-cause mortality after one year, and a 36% reduction in the combined risk of all-cause mortality or hospitalisation for worsening heart failure.

The system transmits clinical and technical data using an antenna in the ICD to the CardioMessenger, an external wireless device. The CardioMessenger transmits the data to the Biotronik service centre, where it is processed and forwarded to a doctor via a secured website. High-priority information is automatically sent directly to the physician via email or text message.

Biotronik's CardioMessenger device

All the ICD companies have monitoring technology like this, but Biotronik’s is the only one on the market that uses daily transmission verification. “That is one of the main differences between the other remote monitoring system and ours. We decided we would have a more frequent and more comprehensive transmission of data compared with other systems.”

Perhaps this is why Biotronik’s meta-analysis showed a benefit for this kind of technology when an academic trial, presented as a Hot Line at ESC, did not. The Rem-HF study found that in heart failure patients with cardiac implantable devices remote monitoring with data collected weekly did not improve outcomes.

The two studies are of course not directly comparable as they involve different technologies and different data delivery schedules.

Biotronik’s meta-analysis is aimed at payers: cutting hospitalisation cuts costs. But there is no direct evidence that its monitoring system is better or cheaper than those offered by rivals.

This question could only be answered by a head-to-head study, and Mr Ortega says no such trial has been done, since the analysis would have to be country-specific – in effect involving many different head-to-head-trials. Biotronik must simply hope that payers are convinced by the data it has.

In-house innovation

Other recent innovations developed in-house include the BioMonitor 2, which is inserted subcutaneously under local anaesthetic to monitor atrial events in patients who have undergone ablation procedures. This was approved by the FDA in April.

The BioMonitor 2, as well as several of Biotronik’s more recent heart pacing devices, incorporates the company’s ProMRI technology.

Mr Ortega explains that when undergoing an MRI a patient must usually visit a clinic to have the MRI-compatible mode on their pacemaker switched on, then return to the clinic to have the MRI-safe mode switched off. This process can leave pacemakers in safe mode for several days. When pacemakers are set to MRI-compatible they can only deliver automatic pacing – and cannot react to any arrhythmia the patient experiences.

Devices with Biotronik’s ProMRI feature automatically detect the high-power magnetic field of an MRI machine, and the device goes into MRI-compatible mode for as long as the patient is in the machine. This limits the time in which the patient is less protected by an automatic pacing mode.

The hope for Biotronik will be that innovations like these will be enough to keep the 53-year old company independent for a little bit longer as competiton from its increasingly larger rivals intensifies.

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

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