We thought it was time for an update on the progress of the Flume catheter. In short, we are making great progress towards our goal of demonstrating the potential of the ‘Flume’ catheter design and bringing it through the necessary regulatory steps to be able to make it available to patients.
We just returned from a trip to our developers in Ireland and can report that the design is now frozen. This is the culmination of months of work to refine the catheter design, ensuring for example that we have the best possible balloon material, and that the combination of a tapered tip profile and good pre insertion shape together with a highly lubricious coating is all optimised for patient comfort.
The next significant step is the ‘First in Human’ trial at centres in Bristol and Southampton which is planned to start in April 2019. The first samples needed for the biocompatibility testing have now been produced. In the three months prior to the trial, the materials and completed devices will be extensively tested independently using a set of methods defined by the US and European regulatory authorities, to make sure they are both safe and effective prior to the first trial in humans.
The Flume catheter has already been tested in freshly excised pigs bladders at the Veterinary School in Bristol along with the glass bladder model at the Bristol Urological Institute (BUI). At a recent Urology Course for Consultant Urologists in Bristol, the device was tested in a cadaver – a recently deceased patient who had left their body to science. All these experiments have given us valuable insights into the functioning of the Flume catheter and how best to configure it for optimal performance. We have even designed an artificial bladder/urethral model in silicone to mimic the real bladder for our balloon testing (and are hoping that the BUI may develop a more comprehensive model to assist further in this work.)
At the beginning of October 2018 I attended the national Royal College of General Practitioner’s Conference in Glasgow since I had a poster about the Flume catheter shortlisted. There were just short of 2000 GPs present along with many Nurses, patients and even Urology registrars. I took the latest prototype with me which helped explain the device to people passing by the poster. I tied it to my badge which made an easy conversation opener – see picture. Everyone was very supportive and I got some particularly helpful input from patient groups.
I was also delighted that the development of the Flume Catheter was featured in a session at BUI’s Annual Scientific Meeting last Friday, dedicated to the legacy of Prof. Roger Feneley (who died suddenly in June). Roger had devoted a substantial part of his long career to highlighting the limitations of the Foley Catheter design and right from my earliest meetings with him he was incredibly encouraging and an inspiration for this project. We have a video of his on the website which he is narrating. Our CEO Roger Holmes attended the presentation by Dr. Nicola Morris and it was followed by a very engaged question and answer session.
I look forward to keeping you up to date with our progress,
Dr John Havard