Vivio® LVEDP System

The Vivio® System is designed to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) in adult patients, serving as an adjunctive tool for healthcare professionals in the diagnosis of heart failure. It employs custom sensor technology, including an arm cuff for brachial artery data and a single-lead EKG patch, to capture waveform data that is then analyzed by a proprietary fixed parameter algorithm to determine if LVEDP is above or below 18mmHg.

The Vivio® System is a medical device indicated for the non-invasive estimation of left ventricular end-diastolic pressure (LVEDP), determining if it is above or below 18mmHg, to assist qualified healthcare professionals in diagnosing heart failure in adult patients as an adjunct to other clinical information. The system comprises an Arm Cuff system with BP cuff electronics, an EKG patch, and a software application run on an off-the-shelf computer tablet. Data is collected non-invasively from the brachial artery using the arm cuff and via a single-lead EKG patch placed on the patient's chest. This collected data is then processed by a proprietary algorithm using a fixed parameter model to provide the LVEDP estimation. A prospective, multi-center clinical validation study was conducted to assess the Vivio System's performance. This study involved 195 subjects in a Cath Lab Cohort, where LVEDP was measured against gold-standard invasive methods (Millar Mikro-Cath), 101 subjects in a Non-aged Healthy Cohort, and 40 subjects in an Aged Healthy Cohort, with the latter compared to non-invasive echocardiographic indices. The study successfully met its primary efficacy objectives, demonstrating a sensitivity of 80% (confidence interval 64–91%) and a specificity of 80% (confidence interval 73–86%) for estimating LVEDP relative to the 18mmHg threshold. The device also underwent non-clinical testing for biocompatibility, electrical safety, electromagnetic compatibility (EMC), and packaging, meeting all predefined acceptance criteria and relevant standards.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the Vivio System's 'fixed parameter model' derive LVEDP estimates from brachial artery pulse and EKG waveforms, and what are the specific physiological parameters it measures and correlates?; What was the spectrum of LVEDP values in the Cath Lab Cohort, and how did the Vivio System's accuracy vary for LVEDP values near the 18mmHg threshold versus those significantly above or below it?; Were any specific patient characteristics (e.g., arrhythmias, hypertension, body habitus) identified that significantly impacted the accuracy or reliability of the Vivio System's LVEDP estimation?; How does the device account for potential confounding factors such as patient movement, improper cuff or EKG patch placement, or variations in peripheral vascular resistance during data acquisition?; Beyond the binary output (above/below 18mmHg), does the system provide any quantitative LVEDP estimate or confidence interval that could offer additional clinical insight?