Fallouh Healthcare wins funding to develop device providing early diagnosis of cardiac tamponade

Birmingham-based Fallouh Healthcare has been awarded €950,000 by the Eureka Eurostar programme to finalise a prototype of PerDeCT, which aims to be the first device for monitoring cardiac function and early diagnosis of cardiac tamponade, a life-threatening complication after heart surgery.

Although cardiac surgery is safe, cardiac tamponade can come on quickly—usually after the patient has left theatre, and typically late at night when the patient is in intensive care.

It is caused by the accumulation of fluid and blood clots that compress the heart, and reduces its ability to pump blood, leading to a decrease in cardiac output and shock. Diagnosis is difficult and subjective, and it can be confused with other causes of heart failure.

PerDeCT is designed to monitor cardiac patients after surgery and provide early diagnosis of tamponade allowing a planned return to surgery to drain fluid and clots around the heart.

The device consists of a probe and a balloon, which is placed in the pericardium (the sac around the heart) during surgery, and measures cardiac efficiency (cardiac output) as well as predicting the development of tamponade, by looking at the trend in the relationship between balloon inflation and cardiac efficiency. It can be withdrawn through the skin after the patient is recovered.

The award will fund a two-year programme of work by Professor Bruno Podesser, Cardiac Surgeon and Professor of Surgery at Medical University of Vienna, Austria, to develop a prototype according to Good Laboratory Practice standards, ensuring regulatory compliance.

He said "The PerDeCT device is like a smart drain we put in every patient. It solves two challenges we have coped with for years. Firstly, it balances the benefit and risk of using devices to monitor cardiac output, and secondly, it is able to detect tamponade easily, before the damage is done. The device is simple, and low cost, and we are excited to join Hazem Fallouh and his team on this exciting journey to make it available to patients."

Fallouh Healthcare is already designing the first clinical trial for PerDeCT, which will take place in the UK and Austria. Following the clinical trial, PerDeCT will be on course for regulatory approval.

Fallouh Healthcare was founded by Birmingham-based Consultant cardiothoracic surgeon Dr. Hazem Fallouh, who has worked in many centres of excellence in the UK, who has previously commercialised two award-winning innovations in cardiac surgery.

He said, "We invented PerDeCT because there are currently no devices that provide an accurate diagnosis, or indicate the patient is on a trajectory where tamponade is likely to occur. As many as 3 in 10 of all deaths that immediately follow post-cardiac surgery are thought to be due to tamponade and we are confident the device can save lives, improve patient outcomes, and reduce the overall costs of cardiac surgery."

The company consists of a team that has first-hand experience of delivering surgical care, and aims to find solutions to address the daily challenges experienced by clinicians, and improve outcomes for cardiothoracic patients.

It has grown rapidly since its incubation at University of Birmingham Enterprise's Unit 9 biomedical incubator, and expects to be fund-raising in the near future.

More information:
For media information contact Ruth Ashton, University of Birmingham Enterprise, email: r.c.ashton@hotmail.com

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About Fallouh Healthcare

Fallouh Healthcare creates innovative medical devices that address pressing unmet needs, save lives and reduce complications in cardiac surgery.

The Pre-clinical investigation of the PerDeCT device (Pericardial Device for monitoring cardiac output and the diagnosis of Tamponade) is funded by Eureka Collaborative R&D (Eurostars Call 7).

Provided by University of Birmingham