Vectorious Medical Technologies has announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for heart failure for its V-LAP left atrial pressure sensor. 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 multicentre first-in-human study—the VECTOR-HF Trial.
William T Abraham, College of Medicine Distinguished Professor at The Ohio State University, Columbus, USA stated: “Worsening heart failure leading to hospitalisation 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, said: “This FDA Breakthrough Device Designation emphasises 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.”
US 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 programme aims to provide patients and health care providers with more timely access to medical devices “by speeding up their development, assessment and review,” including prioritised review all the way through market approval.