Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF).
The Alleviant System is a novel transcatheter device for the creation of a therapeutic interatrial shunt without a permanent cardiac implant. Results were presented at the American College of Cardiology Scientific Session (ACC.21) and at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) by Colin Barker, MD, Director of Interventional Cardiology at Vanderbilt University, Nashville, TN and Jacob Kriegel, MD, Chief Medical Officer of Alleviant Medical.
The reported results of this ongoing first in human study include safety and objective clinical and quality of life outcome measures at one and three-months post-procedure in ten subjects. Data highlights include:
- Confirmed shunt patency in all subjects at 3 months;
- Reduction in mean peak exercise pulmonary capillary wedge pressure (PCWP) by 20% (8 mmHg, p=.026) at 1 month;
- Reduction in mean NT-proBNP by 48% (582 pg/ml, p<.001) at 3 months;
- Increase in mean 6-minute walk distance by 50% (110 meters, p<.001) at 3 months;
- Increase in mean Kansas City Cardiomyopathy Questionnaire overall summary score by 87% (23 points, p<.001, consistent with a large clinical improvement) at 3 months;
- No device-related or procedure-related adverse events through 3 months
“Due to the limited medical or device options to treat heart failure with preserved ejection fraction, providers have few tools for helping patients manage the resulting shortness of breath and reduced quality of life,” commented James Udelson, MD, Chief, Division of Cardiology, Tufts Medical Center, an advisor to the company. “We are encouraged by these early data highlighting outcomes for a no-implant interatrial shunt procedure and look forward to collaborating on further clinical evidence development with the Alleviant technology.”
“Our focus and mission at Alleviant Medical is to deliver a simple, reproducible no-implant interatrial shunt technology to heart failure patients and healthcare providers,” said Adam Berman, CEO of Alleviant Medical. “We are very pleased with the investigator-presented data at these two prestigious cardiology conferences and look forward to subsequent data releases from the ongoing clinical studies with our technology over the upcoming months.”