The Tel Aviv based startup Vectorious Medical Technologies, developing the V-LAP, (a left atrial pressure sensor), last week announced that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for heart failure. 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 multicenter First-in-Human study – the VECTOR-HF Trial.
Heart failure is a chronic disease that affects approximately 27 million patients worldwide, 6 million of them in the US. The progressive, life-shortening disease predominantly afflicts the elderly population 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, stated: “Worsening heart failure leading to hospitalization starts with an elevation of fluid pressure in the heart’s left atrium. 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 stated “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.”
FDA Breakthrough Device Designation is granted to devices that have the potential to offer a “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.” The program aims to provide patients and health care providers with more timely access to medical devices “by speeding up their development, assessment and review,” including prioritized review all the way through market approval. This process facilitates interactive and timely communication between the sponsor and the FDA, as well as the potential to balance pre- and post-market data requirements. To make patient access timelier and more available, the Centers for Medicare and Medicaid Services (CMS) has announced that it is developing a means to expedite reimbursement pathways and to provide increased payments for medical devices designated as breakthrough.