Since the early 1970s, The Griffin Institute has developed extensive expertise in a variety of research models, and supported the testing of numerous medical devices. By providing a refined and tailored service, according to the aims and needs of one’s research, we have been able to achieve many successes with our partners.
Development of an innovative haemostat to control bleeding during surgical procedures Presented by Ben Nichols and Paul Hayes of Selentus Science Ltd
The Griffin Institute performed three haemostasis studies supporting the research and development of our new product, TenaTac®, an innovative surgical haemostat. The Institute’s staff are well trained in surgical procedures and the performance of medical device trials to industry standards. Staff are very responsive and turn- around time on protocols and study arrangements is fast.
Bleeding is a common problem during surgical procedures and haemostats in the form of resorbable sponges or gels are used as treatments. Haemostats also contain blood-derived clotting proteins to enhance their effect and to ensure they adhere to the wound, to prevent dislodgement and post- operative bleeding.
Selentus embarked on a project to develop a haemostat without the use of blood-derived ingredients to reduce the risk to patients from blood derived contaminants. Selentus’ technology is based on a patented laser guided surface modification that greatly increases the adhesion of sponges to wounds. The new product, TenaTac®, was tested at The Griffin Institute.
In addition to eliminating blood derived ingredients, trials at The Griffin Institute have demonstrated that TenaTac® is superior to the leading product with respect to controlling bleeding and adhesion to wounds.
The new product, TenaTac®, was recently approved in Europe as a Class III Medical Device and with a patent granted in the USA, and pending worldwide.
Summative evaluation of a novel cancer detection probe, SENSEI®, in a simulated environment Presented by Dr Kunal Vyas and Miss Francesca Oldfield of Lightpoint Medical Ltd
Summative evaluation of a novel cancer detection probe, SENSEI®, with 10 surgeon participants. The study simulated radio-guided robotic surgery using a pelvic phantom and a robotic system.
To complete simulated, robotic, radio-guided surgery with a pelvic phantom for 10 participants to provide sufficient data to evaluate the safety and effectiveness of the SENSEI® product prior to CE mark, commercial release and clinical trials.
For 10 surgeons to test SENSEI® on a custom 3D printed pelvic phantom with a robotic surgical system in a simulated operating theatre environment.
All 10 participants successfully completed simulated radio-guided surgery using the SENSEI® device. As a result, a summative evaluation report has been written and will contribute toward our EU regulatory submission to attain CE mark.
Staff and facility were willing to go above and beyond to ensure we had the access to the equipment and facilities required, even if this meant scheduling early or late opening hours. Northwick Park medical physics team provided excellent support and guidance on all aspects of radiation safety and was available when needed to confirm that the study activities were safe. Access to the robotic system was an essential part of our study and the robotic surgical system in The Griffin Institute is an excellent resource.
“Great communication with the customer. Professional advice. A lot of effort was made to accommodate our study to meet our timeline.”
“Overall it was a pleasure working with The Griffin Institute and its professional team.”
Biocompatibility study of biomaterials for use as an immune-protective membrane Dr Mehri Behbehani (R&D Scientist) of The Electrospinning Company Ltd
In the UK, approximately 400,000 people are currently living with Type 1 Diabetes (T1D), a serious and lifelong condition where the immune system attacks and destroys insulin-producing beta cells in the pancreas.
Every year, the number of new diagnoses of T1D is increasing by about 4%, and patients have to monitor blood glucose levels carefully and inject insulin. Offering a treatment such as the transplantation of healthy donor beta cells that eliminates the need for insulin injections and reduces the risk of complications would be life changing.
Aim / Challenge
Transplanted beta cells are vulnerable. They need protection from the patient’s immune system and an abundance of nutrients and oxygen to keep them alive.
The advantage of electrospun fibrous membranes is their versatility. The Electrospinning Company used its expert knowledge to create six membrane prototypes using different synthetic polymers, architectures, and thicknesses to be used as immuno-protective membranes for those transplanted cells.
The Griffin Institute was used as a test partner to evaluate the biocompatibility of these membranes and their ability to support a healthy vasculature around its surface.
All membranes tested showed good biocompatibility with minimal foreign body response. One of the materials performed exceptionally well with only mild inflammation in the adjacent tissue. As is often seen with synthetic biopolymers, a thin fibrous capsule formed around the membrane by 21 days, which was however much smaller than the current standard of device materials. There was also an abundance of small blood vessels around the device.
Thanks to the professional team at The Griffin Institute, The Electrospinning Company Ltd was able to select an immuno-protective membrane candidate that is biocompatible and supports good vascularisation.
We are continuing with further studies and working with cell therapy partners to bring this technology to the patient.
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