Cardiovascular medicine: ready for the digital era?
GlobalData’s healthcare team reports on the highlights from the European Society of Cardiology’s 2017 conference in Barcelona, with a special focus on digital health and wearable devices
While covering an expansive number of cardiovascular (CV) indications, this year’s European Society of Cardiology (ESC) conference in Barcelona had a particular focus on digital health.
During the inaugural keynote address on opening day, professor of genomics at the Scripps Research Institute Dr Eric Topol highlighted the need for the field of cardiology to adopt technology that has the potential to improve CV outcomes.
Many start-up companies presented wearable medical devices and portable gadgets that wirelessly transmit collected medical data to mobile devices.
Barcelona-based telehealth device company i-Cardio, for instance, presented a personal and portable electrocardiogram (ECG) system that captures ECG data and transmits it to a patient’s smart phone device via Bluetooth. Another start-up based in Barcelona, LifeVit, presented a mobile app that centralises data collected from a wide variety of wearable devices, including scales, smart watches, pill bracelets, and thermometers, on to a single platform.
A common aspect among the products presented was that if the data on a monitoring device contained an irregularity such as atrial fibrillation, sinoatrial block, or sinus arrhythmia, the patient’s physician would be alerted through a corresponding mobile app.
Market withdrawals amid safety concerns
The withdrawal of Essure from non-US markets follows a dramatic year for the embattled product.
Anvisa, the regulatory agency of Brazil, suspended sales of the device in February 2017, citing product safety concerns. Since then, Bayer has ended distribution in Australia, Canada, Finland, the Netherlands, and the UK.
Additionally, Essure’s CE mark was suspended last month due to unaddressed “queries associated with the recertification review” temporarily halting sales across the EU.
Whether or not the safety concerns about the product are warranted, Bayer now has an image problem with Essure. The reputation of a medical device is always at risk when it becomes the centre of negative mainstream media attention, impacting sales globally as both patients and physicians begin to shy away from the product.
Key opinion leaders interviewed by GlobalData before Bayer’s announcement indicated that sales of Essure were already decreasing.
Furthermore, while Bayer denies the validity of these safety concerns, withdrawing Essure from six markets, including the major markets of Australia, Brazil, Canada, and the UK, clearly does not look good. According to GlobalData, Australia, Brazil, and the UK round out the top five markets for Essure behind the US and France.
However, with sales predominantly coming from the US, what happens in that market will be of the greatest concern to Bayer. As such, all eyes will be on the FDA over the upcoming months.
Essure’s future in the US
Having been notified of well over 10,000 instances of adverse events since the launch of Essure, the FDA applied a boxed warning – the strongest warning issued by the organisation – to the device last year.
Furthermore, Bayer reported involvement in US lawsuits related to the product from approximately 3,700 patients in its 2016 Annual Report.
While the FDA still maintains that Essure is a safe and appropriate procedure for the majority of women, it also ordered Bayer to carry out a new post-market study into the possible long-term risks of the product last year.
Whether or not the FDA will take further action or Bayer decides that it is no longer financially beneficial to keep Essure on the market remains to be seen. According to Bayer’s 2016 Annual Report, impairment losses connected to the Essure device already cost the company $412m in 2016 (at the time of the report’s publication in February).
It is unclear whether the cessation of non-US sales marks the first step in the complete withdrawal of Essure from the market, or revenues from US sales are high enough to justify its continued availability to US physicians. Either way, the decision to keep the product on the US market must be weighed against the impact of global negative media attention, not just in terms of the inevitable increase in legal battles, but also dwindling sales resulting from declining physician confidence.
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