Kiev, Ukraine – December 11, 2017: Clinical Accelerator, a full-service clinical contract research organization, is pleased to announce it has entered into a collaboration with VisCardia Inc. for conducting clinical studies for its VisONE medical device in the Ukraine.
The purpose of the study is to demonstrate the VisONE system improves hemodynamic parameters associated with improved cardiac structure, symptoms and outcomes in patients with chronic heart failure.
VisCardia’s VisOne system is a fully implantable, electronic sensor and electrode system for delivering chronic asymptomatic diaphragmatic stimulation for modulating thoracic pressure augmentation. The system is implanted through a minimally invasive procedure, and programmed for individualized patient use using an external programmer.
According to VisCardia the study intends to demonstrate improvements in accepted “gold standard” cardio physiologic parameters, indicative of patient well-being, while observing clinical heart failure endpoints.
About Clinical Accelerator
Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe, Russia, Ukraine and CIS countries. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological, nutraceutical and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.
VisCardia is a privately held company located in Portland Oregon, USA, developing a novel fully implantable medical device therapy to improve hemodynamic function for managing medical refractory heart failure. Their proprietary approach uses the patient’s own thoracic musculature to improve cardiac filling and output, and relieve symptoms resulting from hemodynamic insuffciency.