Successful Outcomes Seen in First-in-Human Trial of NuPulseCV’s Intravascular Ventricular Assist System (iVAS)

Minimally Invasive Device Would Aid Advanced Chronic Heart Failure Patients

RALEIGH, NC / ACCESSWIRE / February 26, 2018 / NuPulseCV successfully completed an FDA-approved, first-in-human (FIH) trial of its intravascular ventricular assist system (iVAS) last summer. The results of the trial were recently published in the Journal for Heart and Lung Transplantation. Fourteen bridge-to-transplant patients were enrolled in the trial and 13 (92.8 percent) were implanted with the iVAS device. The primary endpoint was survival of patients to transplant, or stroke-free survival at 30 days. At the conclusion of the trial, 12 (92.3 percent) of the 13 iVAS-implanted patients successfully met the primary endpoint. Additionally, 92 percent of patients demonstrated hemodynamics improvements post-iVAS implantation. For advanced heart failure patients needing mechanical support, the continued success with iVAS could mean greatly improved quality of life, with fewer complications.

Comparing patients pre- and post-iVAS implantation, 69 percent of patients were completely weaned off inotropes, medicines that help to change the force of a heart’s contractions. iVAS patients saw a 14 percent increase (1,159 feet at baseline to 1,349 feet from baseline to evaluation before heart transplant) in the six-minute walk test, a commonly used test to examine how a patient’s cardiovascular system responds to exercise. Patient mean time in the ICU post-transplant was six days, with all patients ambulatory within 24 hours of the procedure making ambulation an important component of the recovery process.

The FIH trial took place between April 2016 and April 2017 at the University of Chicago Medical Center. The trial demonstrated the safety of the iVAS device and proved excellent hemodynamic response. The iVAS device has significant clinical potential to provide mechanical support for patients with advanced heart failure. NuPulseCV is the first company to have a first-in-human trial of a mechanical circulatory support (MCS) device on U.S. soil in nearly 20 years.

”Results from our FIH study are promising and demonstrate that iVAS could have a more favorable benefit/risk profile for certain patients, compared to traditional LVADs [left ventricular assist devices],” said Sonna Patel, President of NuPulseCV. ”We’re grateful to the FDA, CMS, and the University of Chicago Medical Center for granting us this opportunity to test the iVAS device here in the U.S. We look forward to a multi-center study, which will be used to evaluate safety and effectiveness of iVAS.”

Figure 1

How it Works

The iVAS device is a blood pump designed to help patients with advanced heart failure. It works by using counterpulsation through a balloon-type device placed in the descending aorta. The device is meant to reduce pressure that the heart must work against, making it easier for the heart to pump blood to the body. The pump is powered by a small, battery-powered console contained in a satchel that can be worn over the shoulder. The implantation of the iVAS device is minimally invasive and requires only a small incision near the left or right clavicle and the placement of electrodes under the skin and a skin interface device (SID), which allows for communication between the implanted components and the external console (see Figure 1).

Advanced Heart Failure

More than 6 million Americans live with heart failure, and about 10 percent of those have advanced heart failure, a condition in which the heart fails to pump enough blood to meet the body’s needs. When standard therapies fail, the condition becomes increasingly worse and progresses to advanced heart failure, then therapies like left ventricular assist devices (LVADs) are used.

The Need for iVAS

iVAS provides a therapeutic alternative for patients whose heart failure may not be so advanced that they require a surgically implanted left ventricular assist pump. The iVAS does not require open-heart surgery and is delivered through a minimally invasive approach, potentially minimizing complications. Patients can be discharged home and remain functional. Traditional surgical left ventricular assist devices provide support but are also accompanied by severe complications such as pump clotting, stroke, bleeding and infections. iVAS may obviate some such complications and provide support in earlier stages of disease to support or even facilitate recovery.

About NuPulseCV Inc.

NuPulseCV is a privately-held, early-stage medical device company based in Raleigh, North Carolina. NuPulseCV is the creator of the intravascular ventricular assist system (iVAS) and the first company to have an FDA-approved first-in-human trial of a mechanical circulatory support (MCS) device on U.S. soil in nearly 20 years. The company was founded in 2012 with the mission to provide novel therapies using advanced technology to increase longevity and improve quality of life for patients suffering from NYHA Class III and ambulatory Class IV heart failure. For more information about the iVAS device or to be considered as a future trial site, visit https://nupulsecv.com/.

Media Contact:

Melisa Vela-Williamson
(210) 413-7421
melissa@mvw360.com

SOURCE: NuPulseCV

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