Israel-based start-up Vectorious Medical Technologies, developing the V-LAP, (a left atrial pressure sensor), has announced that the US FDA has granted the company a Breakthrough Device Designation for heart failure.
Vectorious Medical Technologies receives FDA Breakthrough Device designation
The V-LAP system, which is based on a novel implantable digital and miniature interatrial sensory device for patients with heart failure, is currently assessed in a multi-centre First-in-Human study – the VECTOR-HF Trial.
Heart failure is a chronic disease that affects approximately 27 million patients worldwide, six million of them in the US. The condition predominantly afflicts the elderly with an average age of about 65 at the time of diagnosis.
Dr William T Abraham, M.D., College of Medicine Distinguished Professor at The Ohio State University, said: “With the V-LAP, physicians have a remote access to left atrial pressure – potentially informative and effective data for treating heart failure patients, especially the ones with concomitant pulmonary hypertension and/or mitral regurgitation. Remote monitoring of LAP, has a great potential to keep those patients well and out of the hospital.”
Vectorious Medical Technologies’ CEO Oren Goldshtein added: “This FDA Breakthrough Device Designation emphasizes the critical and unmet need for novel monitoring devices for heart failure. The FDA’s Breakthrough Designation may provide an opportunity for expedited access of this novel patient management approach to heart failure patients who need better treatment options as quickly as possible.”