Boston Scientific acquires Claret Medical, Inc.
Global medical technology leader, Boston Scientific, has acquired privately held company Claret Medical, Inc. the price consists of $220 million in up-front cash, as well as a potential reimbursement-based milestone payment of up to $50 million.
Renowned for developing and commercialising the Sentinel Cerebral Embolic Protection System, used in neurosurgical procedures, such as transcatheter aortic valve replacement (TAVR), the system is the only device cleared to protect patients against the risk of stroke during TAVR and received CE Mark in 2014 and FDA clearance in 2017.
TAVR remains a minimally-invasive procedure, where the aortic valve is replaced in patients with severe aortic stenosis. Embolic debris such as calcium or tissue can break loose during the procedure, travel through the bloodstream towards the brain and potentially cause neurological and neurocognitive damage. Recent studies have estimated approximately four percent of patients experience a clinically-apparent stroke within 30 days of a TAVR procedure.
"Through the development and commercialisation of the Sentinel System, Claret Medical has successfully introduced a new layer of safety and peace of mind for physicians and their patients undergoing TAVR procedures," explained Kevin Ballinger, President, Interventional Cardiology, Boston Scientific.
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"This acquisition will expand our commercial portfolio to include an important adjunctive offering aimed at improving TAVR patient outcomes. We also see potential for future use in other left heart and endovascular procedures such as mitral valve repair and replacement, left atrial appendage closure and pulmonary vein isolation ablation procedures for atrial fibrillation."
In a pivotal SENTINEL trial, the landmark study that led to FDA clearance and commercial introduction of this first-time therapy in the US, the Sentinel System reduced the incidence of strokes by 63% within the first 72 hours of the procedure. In clinical studies, the Sentinel System captured debris flowing towards the brain in 99% of TAVR cases.
"Nearly 10,000 patients have been treated worldwide with the Sentinel System, and we are confident that the leadership of Boston Scientific will enable increased momentum and improved patient access to this valuable technology," stated Azin Parhizgar, PhD, President and Chief Executive Officer, Claret Medical.
The acquisition is projected to close during the third quarter of 2018, subject to customary closing conditions.
The deal follows on from Boston Scientific’s acquisition of Cryterion Medical, where the company aims to further its atrial fibrillation ablation therapy offerings by utilising its ground-breaking cryoballoon platform. The company has been investing in Cryterion since its establishment in 2016, where the system is currently undergoing clinical studies in Europe, with the aim to gain CE and FDA approval.
Slovenia launches EU COVID pass built on Better Platform
Slovenia has launched its EU Digital COVID Certificate, also known as the Digital Green Certificate, which was developed in only three weeks and built on top of a national clinical data repository (CDR) powered by the Better Platform.
The service generates a certificate based on the data available in Slovenia’s national CDR. The COVID certificate uses integrated care record data such as demographic data, vaccination and test result data that is already available. The data is made available through previously established services by the national COVID-19 screening data management solution and the national eVaccination registry – so there is no need for additional data to be generated solely for certificate purposes.
This rapid development of EU Digital Covid Certificate was made possible by an open-platform approach. It has also been created so that it can used by different systems, providing a vendor-neutral exchange of documents, and is available on-demand in digital or PDF form, with QR codes.
The COVID-19 pandemic pushed national health systems to quickly develop new digital solutions for including to manage epidemiological data, and organise COVID-19 tests and vaccinations. The EU Digital COVID Certificate is the latest example of a solution that was developed at this new fast pace to allow citizens to travel safely this summer.
The Slovenian healthcare system already had a national eHealth infrastructure, enabling data to be shared via an integrated care record that makes data available for any digital service instantly, at scale and volume.
Currently, Slovenia's healthcare system includes:
* more than 150 million health records for 2.1 million unique individuals (98% of the population)
* more than 86% (135 million) of records in the form of structured data that uses openEHR models
* more than 4 million records of COVID-19 test results
* unstructured data that includes discharge summaries, clinical notes, opt-in statements, consent documents and other clinical data
* data which is sent to the national system by more than 1,250 registered healthcare providers in Slovenia
Initially, the digital health platform enabled the Slovenian Ministry of Health to respond rapidly and deploy a COVID-19 screening data management solution on a county-wide level in just 14 days. With vaccination data available through the national eVaccination registry, there was no need for additional data to be generated solely to create the COVID certificate.
“We are happy that we already had the suitable IT infrastructure in place in Slovenia" said Minister of Health Janez Poklukar. "It allowed us to respond quickly and provide the necessary digital solutions that support the efforts of medical and epidemiological teams to manage the pandemic, as well as to allow our citizens to travel freely.”