Tel Aviv, Isreal-based startup Vectorious Medical Technologies has secured a breakthrough device designation from FDA for a new heart failure monitoring device. The V-LAP (a left atrial pressure sensor) system is based on a implantable digital and miniature interial sensory device for heart failure patients and is currently in a multicenter first-in-human study dubbed the VECTOR-HF trial.
William T. Abraham, MD, College of Medicine Distinguished Professor at The Ohio State University, explained that 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 those with concomitant pulmonary hypertension and/or mitral regurgitation, he said, adding that remote monitoring of left atrial pressure has the potential to keep those patients well and out of the hospital.
Vectorious CEO Oren Goldshtein said the designation from FDA emphasizes the critical and unmet need for new 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," Goldshtein said.
FDA's breakthrough device designation program aims to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The program replaced the agency's expedited access pathway program and priority review for medical devices.