Clinical Accelerator has recently entered into a new collaboration with CroíValve – a medical device company from Ireland – who is developing a novel, easy to use percutaneous solution for treating patients with severe Tricuspid Regurgitation (TR).
Tricuspid Regurgitation is an unmet medical need that affects over 550 thousand new patients every year in the US and EU alone. It often occurs in heart failure patients due to tricuspid annular dilation. Prognosis is poor for those affected and less than 1% of patients can undergo surgical treatment due to co-morbidities. Even for patients who can receive treatment, the operative mortality rate is between 10% to 35%.
Croívalve is dedicated to bringing an innovative solution to this area with their minimally invasive device that repairs the tricuspid valve without requiring surgery. The device will be placed across the native valve assisting coaptation and is held in place by a non-penetrating anchoring system. The device intends to provide patients with improved and extended quality of life and physicians with safe and easy treatment.
Croívalve announced first successful human use of its technology in March this year. The procedure was carried out at St James’ Hospital (Dublin, Ireland) and involved delivery and retrieval of the device fully percutaneously, with the device delivered without complications in the space of five minutes. It was published that the patient who suffered from severe TR with reduced heart function, experienced positive cardiac response to the treatment (Innovator, 2020).
Clinical Accelerator is excited to be participating in a new clinical study by Croívalve assessing the feasibility, safety and performance of temporary implantation of the device in TR patients prior to surgical intervention.
Croívalve is an early stage medical device company focused on developing a minimally invasive device for the treatment of tricuspid regurgitation. It is based in Dublin, Ireland and combines significant clinical, technical and commercial experience.
About Clinical Accelerator
Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.