Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021

HomeIntralink SpineNew Data for Intralink-Spine’s Réjuve Treatment for Low Back Pain

New Data for Intralink-Spine’s Réjuve Treatment for Low Back Pain


“We’ve demonstrated the safety of this device, and it has performed as expected. The dramatic pain reduction in these patients correlated with some objective measures: there was an average increase in lumbar range of motion of 9 degrees and there was a statistically significant 25% increase in treated level lordosis, based on kinematic data analysis performed by Medical Metrics Inc. Decreased lumbar lordosis is known to be related to disc degeneration and back pain, especially when standing,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky.

Additional findings at the six-month juncture from its early safety and feasibility study, Intralink-Spine, Inc. (ILS) indicates that the Réjuve™ System effectively eliminates or reduces low back pain.

“We’ve demonstrated the safety of this device, and it has performed as expected. The dramatic pain reduction in these patients correlated with some objective measures: there was an average increase in lumbar range of motion of 9 degrees and there was a statistically significant 25% increase in treated level lordosis, based on kinematic data analysis performed by Medical Metrics Inc. Decreased lumbar lordosis is known to be related to disc degeneration and back pain, especially when standing,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky.

“I was also excited to see that the only symptomatic disc in these first few low back pain patients that was shown to be clinically unstable pre-treatment (QSI = 2.5, meaning the instability as quantified by translation per degree of rotation (TPDR) was 2.5 standard deviations above the mean for an asymptomatic, radiographically normal population) was effectively stabilized by the Réjuve treatment. This previously symptomatic and unstable segment was asymptomatic (no pain and no disability at 1 month through 6 months) and stable with a normal TPDR (QSI = -0.1). This result illustrates and affirms one of the mechanisms for pain relief associated with this product,” says Dr. Hedman.

“After a six-month period, 80% of patients had excellent results (pain and disability reduced >50%). Patient data are also showing the Réjuve Treatment is “fast acting” – treatment effects seen at 2-weeks post-procedure continued or improved through 6-months in 80% of patients treated. Think of it, the positive effects of Réjuve are both rapid and long-lasting,” says Lyle Hawkins, CEO of Intralink-Spine, Inc. “Low back pain (LBP) is a challenging condition to treat, which is why we’re excited about our data thus far and another reason we’re excited about our studies underway in Malaysia and Canada.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

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