News | Heart Failure | June 15, 2021

VoluMetrix's NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients.


June 15, 2021 — VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its NIVAHF device has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients, and represents the company's flagship application for its Non-Invasive Venous waveform Analysis (NIVA) technology. Development of NIVAHF, which is being prepared for submission for De Novo regulatory clearance, is supported by a Fast-Track grant provided by the National Institutes of Health (NIH) and LaunchTN SBIR/STTR Matching Fund Program. As part of the Breakthrough Device program, FDA will work closely with VoluMetrix to advance pre-commercial development of NIVAHF and prioritize the review of subsequent regulatory submissions.

The intended purpose of the NIVAHF device is to provide a proprietary NIVA Score that corresponds to a pulmonary capillary wedge pressure, or PCWP. Currently, this clinically important value can only be obtained through invasive catheterization of the heart and vasculature. NIVAHF provides a non-invasive solution in heart failure care — taking this from hospital to home.

"We are thrilled that FDA has recognized NIVAHF as a Breakthrough Device with important prospective clinical applications," said Kyle Hocking, Ph.D., President & CEO of VoluMetrix. "NIVAHF is the culmination of our organization's talent, intellect, passion, and hard work. It represents the first of many potential vehicles for our NIVA vital monitoring technology, and we look forward to working closely with regulators to expedite its development and regulatory review. Ultimately, our mission is to improve the care experience for as many heart failure patients as possible, as quickly as possible. This designation is a powerful milestone in that journey, and we are grateful for it."

The NIVA technology represents a major innovation in vital monitoring technology. NIVA was developed to optimize hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient's waveform), and signal decoding.

What is the Venous Waveform?
The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate and respiration, as well as intravascular and extravascular dynamics.

About Breakthrough Device Designation
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request ("De Novo request").

This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

For more information about this designation: https://www.fda.gov/media/108135/download

For more information: www.volumetrix.com

 


Related Content

News | Heart Failure

November 22, 2022 — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with ...

Home November 22, 2022
Home
News | Heart Failure

November 21, 2022 — Cardiovascular disease remains the leading cause of death in the United States (US) and worldwide ...

Home November 21, 2022
Home
News | Heart Failure

November 22, 2022 — Myocarditis is a complication that can occur in cancer patients treated with immune checkpoint ...

Home November 21, 2022
Home
News | Heart Failure

November 15, 2022 — Ten months after transplanting the first genetically-modified pig heart into a human patient ...

Home November 15, 2022
Home
News | Heart Failure

November 14, 2022 — When it comes to heart failure (HF), sex differencesare known to impact everything from risk factors ...

Home November 14, 2022
Home
News | Heart Failure

November 9, 2022 — Lexicon Pharmaceuticals, Inc. announced that a new analysis of results from the SOLOIST-WHF Phase 3 ...

Home November 09, 2022
Home
News | Heart Failure

November 3, 2022 — Chronic heart failure causes the cell’s powerhouses to dysfunction, in part due to overconsumption of ...

Home November 03, 2022
Home
News | Heart Failure

October 28, 2022 — V-Wave, announced today the completion of enrollment in RELIEVE-HF, a prospective, randomized, double ...

Home October 28, 2022
Home
News | Heart Failure

October 27, 2022 — Vascular surgeons from Allegheny General Hospital (AGH) Cardiovascular Institute, the flagship ...

Home October 27, 2022
Home
News | Heart Failure

October 19, 2022 — For men and women, the risk factors for cardiovascular disease are largely the same, an extensive ...

Home October 19, 2022
Home
Subscribe Now