The Fifth IFSO Global Registry Report (2019) has been released at the XXIV World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) in Madrid, Spain. Published by Dendrite Clinical Systems, under the auspices of the IFSO, the publication reports data from more than 60 countries on over 833,000 operations including baseline obesity-related disease, operation types, operative outcomes and disease status after bariatric surgery.
Dendrite Clinical Systems has announced the installation of its National Bariatric Surgical Registry software at the Sheik Al Jaber Al Sabah Hospital, in Kuwait. The Sheik Al Jaber Al Sabah Hospital, opened by His Highness the Amir Sheikh Sabah Al-Ahmad Al- Jaber Al-Sabah in November 2018, consists of five towering 10-stories structures built on a 220,000 square meters and has a hospital bed capacity of around 1,160 with 36 operation rooms, a medical centre, a helipad and a parking lot accommodating some 5,000 vehicles.
Dendrite Clinical Systems and the Queen Mary Hospital in Hong Kong have launched the Asian Hypospadias Outcome Registry (AHOR), is a prospective web-based patient registry that will collect, record and analyse the treatment and outcomes of patients undergoing surgical repair.
Dendrite Clinical Systems has launched its ‘One-button push’ outcomes module, allowing clinicians to instantly produce their outcomes with the push of a single button. This enhancement is the latest in a series of advances incorporated into the company’s clinical registry software.
Dendrite Clinical Systems, the publisher of Bariatric News, is pleased to announce issue 40 of the newspaper is now available to view/download. The newspaper reports on research, technology, events and policy in the bariatric specialty, the latest clinical studies, policy changes and product news, the latest meetings and events, interviews prominent bariatric experts, and host debates between specialists on controversial topics.
Dendrite Clinical Systems – in collaboration with Haemotology Cancer Care (UCLH Charity), the Royal Free Charity, HaemSTAR (an organisation researching non-malignant haematology) and MPN Voice – have launched the MASCOT (Myeloproliferative Neoplasm Splanchnic Vein Thrombosis, MPN-SVT) Registry, a UK wide registry for patients with myeloproliferative diseases suffering from splanchnic or abdominal vein thrombosis.
Dendrite Clinical Systems Ltd and Device Access UK collaboration helping MedTech companies to expedite UK NICE approvals and reimbursement
For nearly a decade, Dendrite Clinical Systems and Device Access UK have been combining their expertise in clinical registries and market access and reimbursement, respectively, to expedite the regulatory processes for MedTech companies to get their technologies to patients. Working in conjunction with small, medium and large multinational companies, the partnership has enabled clients to record, collect and analyse real-world evidence and present data that adheres to the necessary regulatory guidance and requirements.
“The UK regulatory process for reimbursement requires peer-reviewed published data from a number of sources including randomised controlled trials (RCTs) and clinical registries,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “Clinical registries are main source of observational large-scale evidence-based data and can be specifically designed to examine the effectiveness of pharmaceuticals, medical devices, treatments or procedures.”
Achieving regulatory and reimbursement approval can be long, exhaustive and expensive. In England, the National Institute for Health and Care Excellence (NICE) is responsible for producing evidence-based guidance and publishes regular appraisals that make recommendations on the use of new and existing medicines and treatments within the NHS. The NHS is legally obliged to fund and resource medicines and treatments that NICE has recommended.
As part of appraisal evaluations, NICE requires peer reviewed, published or presented data, demonstrating treatment from a UK care pathway. In addition, they also require patient-reported outcome measures (PROMs) to examine the impact the technology or treatment has on the patient’s quality of life (mental health, lifestyle etc).
“Gathering, analysing and presenting robust data is a key element in gaining approval from NICE and clinical registries are a proven approach to collecting and interpreting real-world evidence for MedTech companies,” explained CEO of Device Access UK, Michael Branagan-Harris. “In addition, far longer-term PROMS data is fast becoming a very desirable element of the NICE Interventional Procedure (NICE IPG) appraisals evaluation process, and Dendrite are one of the few companies who are able to incorporate a PROMS module as part of their bespoke clinical registry software package.”
Over the years, Dendrite Clinical Systems and Device Access have worked together across an array of specialities including interventional radiology, urology and vascular surgery to guide numerous companies through the reimbursement and NICE evaluation processes by developing registries that have informed NICE about a product's use, treatment patterns (standards of care), benefits and cost effectiveness, and helped them gain market access.
“In our experience, collecting data needs to be a finely tuned process, and it is crucial companies understand exactly what data NICE requires,” added Dr Peter Walton. “Device Access has unparalleled experience in guiding clients through the reimbursement minefield and it has been a great pleasure to work with them over the years,” added Dr Peter Walton. “Our two companies have a shared ethos - helping our clients to get their technology to the market to improve outcomes for patients. Our partnership has opened up new opportunities for both our companies and we look forward to many more successful collaborations in the future.”
About the companies
For nearly 30 years, Dendrite Clinical Systems’ specialist clinical databases have enabled the international healthcare community to gather evidence-based medicine to improve patient outcomes and professional practice. The company has developed more than 200 local, national and international registries that have collected data on patients, procedures, devices, pharmaceuticals and therapeutics, and their flexible “Intellect-Web” software can be adapted to any clinical scenario.
Established in 2010, Device Access UK is a dedicated medical technology reimbursement consultancy providing support for MedTech companies entering the UK National Health Service. The company enables the efficient adoption of medical technologies into healthcare systems by demonstrating their true value to the patient, the provider and the payer. To date Device Access has supported over 40 companies though NICE Evaluations.
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As part of the larger IGES MedTech group, they are also able to support MedTech companies into European markets.
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