Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device.
The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, company officials believe the feedback provided by the V-LAP will enable a significant improvement in heart failure management.
Vectorious began conducting clinical studies in Italy, Germany, the UK and Israel in 2019 for the purpose of obtaining a CE mark. It expects to launch a U.S. clinical study in 2022.
“Worsening heart failure leading to hospitalization starts with an elevation of fluid pressure in the heart’s left atrium,” said Dr. William T. Abraham, of The Ohio State University College of Medicine in a news release. “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.”
“This FDA Breakthrough Device Designation emphasizes the critical and unmet need for novel monitoring devices for heart failure,” added Vectorious Medical Technologies’ CEO Oren Goldshtein. “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.”