Tuesday, October 3, 2023
Tuesday, October 3, 2023

Contact: 561.316.3330

PainTEQ’s Multicenter Real-World Study Reports Long-Term Efficacy and Safety

A new multicenter real-world study of PainTEQ’s LinQ device reflected long-term success and safety in treating sacroiliac (SI) joint dysfunction.

The LinQ SI Joint Stabilization System is a minimally invasive procedure that utilizes a single allograft to encourage long-term fusion and help patients immediately regain joint stability. The study followed 50 patients who received a LinQ implant. The overall average percent of pain relief after treatment was 66.5% at an average follow-up of 613 days (20 months).

“I believe this publication on the real-world experience to date of the LinQ Fusion System is critically important. Although controlled prospective studies are considered the gold standard, published real-world experience is equally important as it often translates more to everyday clinical practice,” said Dawood Sayed, M.D., Professor of Anesthesiology and Pain Medicine at the University of Kansas Medical Center and one of the lead researchers on the project. “The success and long-term outcomes data for almost two years from this study show impressive long-term durability and excellent safety.”

Low back pain presents a hefty burden on the U.S. healthcare system. However, some cases of back pain are not related to the spine at all but rather SI joint dysfunction. Chronic SI joint pain may fail to respond to conservative treatment such as physical therapy and SI joint injections. Therefore, LinQ provides a minimally invasive option to promote long-term stabilization.

“PainTEQ’s LinQ has resulted in prolonged positive impact on our patients suffering from chronic SI pain,” said Stephen Pyles, M.D., the second lead researcher involved in the project. “I can say this treatment has changed my practice and is one of the more rewarding procedures I do as an interventional pain doctor. I’m confident the data will continue to show sustained pain relief over the next year for these patients.”

This multicenter review followed the patients of three physicians across three institutions – both academic and private – and demonstrated that a minimally invasive, posterior SI joint fusion with LinQ could reduce overall pain in patients with persistent sacroiliitis.

“Promising long-term results from this real-world study continue to add to the growing body of evidence for the LinQ System. We are excited to help more patients suffering from sacroiliac pain as we expand the commercial reach of the LinQ System,” said Shanth Thiyagalingam, Chief Commercial Officer at PainTEQ.

Medical Device News Magazinehttps://infomeddnews.com
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!

4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

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."

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