Saturday, September 23, 2023
Saturday, September 23, 2023

Enrollment of the VasQ External Support US Pivotal Study Now Complete

Laminate Medical Technologies announced the completion of enrollment into the VasQ External Support US Pivotal Study.

The study was conducted at 17 sites across the U.S. and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for hemodialysis.  Both brachiocephalic and radiocephalic AVF patients were included in the study.  The patients will be followed for two years with the primary endpoint of primary patency analyzed at six months.

AVFs are the preferred vascular access to deliver hemodialysis treatment due to the low rates of infection and mortality relative to alternative options for patients.  However, the natural biologic responses to the changes in hemodynamics and mechanical stress at the vein wall from the arterial flow tends to induce in inward tissue growth and ultimately AVF failure.  Reported failure rates for AVFs are as high as 60% and require costly additional procedures to correct or a new AVF creation altogether.

VasQ is designed to address both the hemodynamic and mechanical factors associated with AVF failure.  The device is a nitinol external support placed around the artery and vein at the creation site that optimizes the transition of arterial flow to the vein while reinforcing the vessel wall against the increase in mechanical stress.  VasQ patients in Europe have demonstrated increased rates of receiving a usable AVF with fewer early failures and additional procedures in multiple prospective and retrospective studies.  The clinical benefits of VasQ experienced in Europe are expected to be validated in the US dialysis patient population within this fully enrolled pivotal study.

Prof. Ellen Dillavou, MD, FACS, of Duke University stated, “VasQ promises to be a new standard of care for fistula creation to give my hemodialysis patients the greatest probability of success.  The device has performed as expected in my study patients so far, and I look forward to continuing to utilize it once commercially available in the U.S.”

“We are grateful to our principle investigators for their commitment to this study,” said Laminate CEO Tammy Gilon.  “The results will be an important addition to the mounting evidence supporting the benefits of VasQ to promote the usability of both forearm and upper arm fistulas.”

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury

Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures. Receives FDA Clearance and Breakthrough Device Designation has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program.

By using this website you agree to accept Medical Device News Magazine Privacy Policy