The US Food and Drug Administration (FDA) has granted Tel Aviv-based start-up Vectorious Medical Technologies a breakthrough device designation for left atrial pressure sensor, V-LAP, for heart failure.
V-LAP is the first in-heart microcomputer and is based on a new implantable digital and miniature interatrial sensory device for heart failure patients.
The digital, wireless, battery-less device monitors the heart’s left atrium pressure (LAP) and can communicate from deep within the body.
LAP is proven to be the earliest, most precise, and effective predictor for heart failure deterioration.
The device is currently being assessed in a multi-centre first-in-human VECTOR-HF Trial.
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 to 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 can potentially offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
The Ohio State University College of Medicine professor Dr William Abraham said: “With the V-LAP, physicians have 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 is currently carrying out clinical trials in Italy, Germany, UK, and Israel to obtain a CE mark and plans to initiate a study in the US in 2022.