Boston Scientific agrees purchase of Apama Medical for up to $300mn
Medical technology innovator Boston Scientific Corporation is set to buy Apama Medical in order to expand its expertise in electrophysiology.
Paying an initial $175mn, the fee could rise to $300mn between 2018 and 2020 based on achievements of clinical and regulatory milestones.
The technology in question concerns treatment of atrial fibrillation (AF), a common heart rhythm disorder estimated to affect more than 33mn people worldwide.
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The standard of care in AF ablations is pulmonary vein isolation (PVI) – the application of energy to create lines of scar tissue around the pulmonary veins in the left atrium to block unwanted electrical signals that trigger AF. PVI is currently performed using two different technologies: point-by-point RF-based ablation and single-shot balloon-based ablation.
The Apama RF balloon – a single-shot, multi-electrode technology – is designed to combine the primary benefits of both RF point-by-point and balloon-based ablation approaches, notably the ability to deliver differentiated levels of energy and shortened procedure times.
The technology incorporates built-in digital cameras with LED lights and sensing electrodes on the balloon which allow for real-time visualisation and assessment of catheter electrode contact. This is intended to provide physicians with higher confidence of effective energy delivery and the ability to customise the amount of energy delivered around the circumference of the balloon, while further reducing procedure times when compared to existing balloon technologies.
Joe Fitzgerald, president of Rhythm Management, Boston Scientific, said: “The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialisation, would broaden our portfolio of differentiated arrhythmia solutions.
"We are also excited about the ability to integrate the Apama RF balloon system with our RHYTHMIA HDx Mapping System to provide physicians with an unprecedented visualisation of the heart during ablation procedures."
The Apama RF balloon is currently being studied in clinical trials in Europe to serve as the basis for CE mark approval, which is expected in late 2018.
Getting ready for cloud data-driven healthcare
As healthcare continues to recognise the value of data and digital transformation, many organisations are relying on the cloud to make their future-forward and data-centric thinking a reality. In fact, the global healthcare cloud computing market was valued at approximately $18 billion and is expected to generate around $61 billion USD by 2025.
At the forefront of these changes is the rapid adoption of cloud-based, or software-as-a-service (SaaS), applications. These apps can be used to handle patient interactions, track prescriptions, care, billing and more, and the insights derived from this important data can vastly improve operations, procurement and courses of treatment. However, before healthcare organisations can begin to dream about a true data-driven future, they have to deal with a data-driven dilemma: compliance.
Meeting regulation requirements
It’s no secret that healthcare is a highly regulated industry when it comes to data and privacy – and rightfully so. Patient records contain extremely sensitive data that, if changed or erased, could cost someone their life. This is why healthcare systems rely on legacy technologies, like Cerner and Epic EHRs, to manage patient information – the industry knows the vendors put an emphasis on making them as secure as possible.
Yet when SaaS applications are introduced and data starts being moved into them, compliance gets complicated. For example, every time a new application is introduced into an organisation, that organisation must have the vendor complete a BAA (Business Associate Agreement). This agreement essentially puts the responsibility for the safety of patients’ information — maintaining appropriate safeguards and complying with regulations — on the vendor.
However, even with these agreements in place, healthcare systems still are at risk of failing to meet compliance requirements. To comply with HIPAA, U.S. Food and Drug Administration 21 CFR Part 11 and other regulations that stipulate the need to exercise best practices to keep electronic patient data safe, healthcare organisations must maintain comprehensive audit trails – something that gets increasingly difficult when data sits in an application that resides in the vendor’s infrastructure.
Additionally, data often does not stay in the applications – instead healthcare users download, save and copy it into other business intelligence tools, creating data sprawl across the organisation and exposing patient privacy to greater risk.
With so many of these tools that are meant to spur growth and more effective care creating compliance challenges, it begs the question: how can healthcare organisations take advantage of the data they have without risking non-compliance?
Yes, healthcare organisations can adhere to regulations while also getting valuable insights from the wealth of data they have available. However, to help do this, organisations must own their data. This means data must be backed up and stored in an environment that they have control over, rather than in the SaaS vendors’ applications.
Backing up historical SaaS application data directly from an app into an organisation’s own secure cloud infrastructure, such as AWS or Microsoft Azure, makes it easier, and less costly, to maintain a digital chain of custody – or a trail of the different touchpoints of data. This not only increases the visibility and auditability of that data, but organisations can then set appropriate controls around who can access the data.
Likewise, having data from these apps located in one central, easily accessible location can decrease the number of copies floating around an organisation, reducing the surface area of exposure while also making it easier for organisations to securely pull data into business intelligence tools.
When healthcare providers have unfettered access to all their historical data, the possibilities for growth and insights are endless. For example, having ownership and ready access to authorised data can help organisations further implement and support outcome-based care. Insights enabled by this data will help inform diagnoses, prescriptions, treatment plans and more, which benefits not only the patient, but the healthcare ecosystem as a whole.
To keep optimising and improving care, healthcare systems must take advantage of new tools like SaaS applications. By backing up and owning their historical SaaS application data, they can do so while minimising the risk to patient privacy or compliance requirements. Having this ownership and access can propel healthcare organisations to be more data-driven – creating better outcomes for everyone.