Thermocore Medical Completes Thermography Device Trial

Thermocore Medical Ltd. has successfully completed a patient safety and feasibility trial for its Thermosense coronary temperature assessment system.

Conducted at the Middleheim Hospital, Antwerp by Dr Paul Vermeesch, the trial met its primary end-points, demonstrating that the Thermosense system successfully recorded intracoronary temperature profiles in all patients with no major adverse cardiac events.

Results of the study will be presented by Dr Stefan Verheye, also of the Middleheim Hospital, Antwerp, at the scientific sessions of the 2002 Transcatheter Cardiovascular Therapeutic (TCT) meeting on Wednesday 25 September in Washington DC, USA.

Further data on the Thermocore system is to be presented at the TCT Vulnerable Plaque symposium by Prof. Patrick Serruys, Head of Thoraxcentre Rotterdam, who will report on a thermographic clinical trial comprising patients with stable or unstable angina who were scheduled to undergo a diagnostic angiogram or intervention.

Commenting on the results, Dr Vermeesch said "We have demonstrated that the Thermosense thermography catheter can successfully be deployed in the human coronary artery, that the system can record intracoronary temperatures and show temperature heterogeneity along the arterial wall, and that the system is safe for clinical use in the coronary arteries. The system worked well in practice and represents a potentially major step forward which has the advantage of being grounded in the diagnostic angiography procedure which is familiar to cardiologists everywhere."

The potential role that thermography could play in future diagnostic systems is explained by Prof. Serruys. "Unstable plaques, also known as vulnerable plaque or 'VP', are thought to be the most common cause of heart attack and death. Current techniques such as angiography can't distinguish between vulnerable and stable plaques, so we can't tell which patients are walking round with a potentially deadly time bomb inside them. But we do know that inflamed tissue is hotter than healthy tissue, so we think that one of the possible routes to identifying these vulnerable plaques - and a first step to doing something about them - is to measure the temperature in the coronary artery walls and look for abnormalities. I envisage that the Thermosense system now being developed by Thermocore could allow doctors to take the angiography procedure one step further by detecting these unstable plaques in their early stages and allowing the doctor to start the patient on an appropriate course of preventive or stabilising treatment."

Thermocore's intracoronary thermography system comprises a thermography catheter with a functional probe containing four thermistors which engage with the endoluminal surface of the artery after retraction of a protective sheath. These thermistors perform up to 25 measurements per second with an accuracy of 0.01 degrees Celsius. A dedicated, catheter-specific pullback device holds the catheter and is capable of withdrawing it with thermistors engaged with the artery's surface at an operator-defined speed. The thermography catheter is connected to a console which overlays the data acquired on to the conventional angiographic image in a visual, real time and clinician-friendly format.

Dr John Yianni, Thermocore's CEO, expressed his delight at the speed with which CE Mark approval had been achieved. "To have the successful conclusion and presentation of our first clinical trial coincident with the granting of ISO 9001 and EN 46001 certification and CE Mark approval for our catheter is a huge boost for the company and an important validation of our technology. It opens the way to further investigation into the clinical indications in which our proprietary Thermosense system is applicable, and to commercialization of our products."

Thermocore Medical, a private company set up in 2000 and funded by venture capital, is based in Guildford, UK. Thermocore is active in the field of interventional cardiology and has developed a unique and novel, catheter-based system which may in future have indications in the location and visualisation of unstable plaques within coronary arteries.