LUMEVAC™: Novel EVT Technology – Cambridge University Hospitals NHS Trust

LUMEVAC™ – A pioneering endoscopic surgical device

Each year, around 2,800 people in the UK experience a hole in their upper gastrointestinal (GI) tract. These holes may occur on their own; arise from problems such as stomach ulcers; or be caused through surgery or other medical interventions. The presence of a hole allows leakage of gastrointestinal contents into the body which quickly leads to infection – a serious medical emergency that can be fatal if not treated.

In the past, the standard treatment for these holes has been surgery, but this can often be unsuccessful. More recently surgeons have developed an alternative treatment strategy for this problem called Endoluminal Vacuum Therapy (EVT). However, this treatment still requires multiple technically difficult procedures under general anaesthesia in an operating theatre.

HTE supported the clinical team during the early stages of development to protect the intellectual property, apply for and secure grant funding for the project, and to identify a suitable commercial partner who could bring the product to market.

Technology

Anastomotic leakage, a defect or hole in the GI tract, is a severe complication of esophagectomy and other procedures and is associated with prolonged stay in intensive care, a reduced quality of life, high costs and an increased mortality rate. GI leakage into the chest, mediastinum and upper abdomen results in a significant sepsis a serious medical emergency that is fatal if not treated successfully.

Management is challenging, especially in patients with delayed presentation. Traditionally this involved a combination of surgery, radiological drainage and enteral stenting. Patients usually require multiple interventions to drain sepsis and achieve source control.

More recently surgeons have developed an alternative treatment strategy for this problem called Endoluminal Vacuum Therapy (EVT). While EVT has been shown to improve mortality rates compared to surgery this treatment still needs improvement as it requires multiple technically difficult procedures under general anaesthesia in an operating theatre to be successful.

LUMEVAC™, currently in development, is a ground-breaking progression of EVT that allows easier delivery of treatment without the need for general anaesthesia, meaning the procedure does not need to be performed in an operating theatre. LUMEVAC™ makes EVT safer, quicker, easier and cheaper, and importantly is far less traumatic for patients. It will also enable patients to be mobile during treatment, unlike standard EVT, where patients are often confined to their hospital beds.

LUMEVAC™ was invented by a team led by Mr Andrew Hindmarsh, Consultant Oesophagogastric Surgeon at Cambridge University Hospitals NHS Foundation Trust and including researchers based at the University of Cambridge.

Commercialisation

HTE has collaborated closely with the clinical team during the early phases of development, including filing the original patent application and helping to secure proof of concept funding through the Medtech Accelerator. LUMEVAC™ is also backed by a £1.2m grant from the National Institute for Health Research (NIHR), which has a number of regional specialist partners including HTE, the Cambridge University Hospitals, the Cambridge Clinical Trials Unit and Suffolk-based JEB Technologies Ltd.

Medical Device Manufacturer Medovate secured the exclusive rights to develop, manufacture and sell this ground-breaking surgical innovation in 2019. Medovate’s role will now be to attain regulatory approval and clinical evaluation, with a view to market launch thereafter.

 

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