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

March 5, 2023 — Doctors who received customized electronic health record (EHR) alerts for specific patients were 2.5 ...

Home March 05, 2023
Home
News | Heart Failure

March 4, 2023 - Lexicon Pharmaceuticals, Inc. announced new analyses of results from the SOLOIST-WHF Phase 3 outcomes ...

Home March 04, 2023
Home
News | Heart Failure

March 3, 2023 — Researchers may be able to predict cardiovascular disease – such as atrial fibrillation and heart ...

Home March 03, 2023
Home
News | Heart Failure

February 24, 2023 — Abiomed, Inc., part of Johnson & Johnson MedTech[1], announced that results from a study on Impella ...

Home February 24, 2023
Home
News | Heart Failure

February 23, 2023 — Lexicon Pharmaceuticals, Inc. announced the upcoming presentation of new analyses of results from ...

Home February 23, 2023
Home
News | Heart Failure

February 22, 2023 — CVRx, Inc., a commercial-stage medical device company focused on developing, manufacturing and ...

Home February 22, 2023
Home
News | Heart Failure

February 2, 2023 — Technology is continuously evolving, and so is the approach taken by transplant cardiologists at ...

Home February 02, 2023
Home
News | Heart Failure

January 25, 2023 — Adults living in rural areas of the United States have a 19% higher risk of developing heart failure ...

Home January 25, 2023
Home
News | Heart Failure

January 24, 2023 — Leakage of the mitral valve due to degenerative prolapse is a common condition known as primary ...

Home January 24, 2023
Home
News | Heart Failure

January 18, 2023 — Phone calls from a nurse may improve survival for patients treated for heart failure, according to a ...

Home January 18, 2023
Home
Subscribe Now