Sacroiliac joint dysfunction

PainTEQ Announces Successful Completion of First In-Office LinQ Procedure Under New CMS Billing Code

Retrieved on: 
Thursday, January 18, 2024
Physician, Medicare, Sacroiliac joint dysfunction, Subluxation, Patient, LinQ, CMS, Safety, MD, Hospital

The patient who underwent the LinQ procedure experienced a quick and comfortable recovery, highlighting the procedure's efficiency and the benefits of an in-office setting.

Key Points: 
  • The patient who underwent the LinQ procedure experienced a quick and comfortable recovery, highlighting the procedure's efficiency and the benefits of an in-office setting.
  • The patient's positive feedback on the ease and convenience of the procedure underscores its potential to transform SI joint dysfunction treatment.
  • PainTEQ CEO Sean LaNeve added, "This is a groundbreaking moment for PainTEQ and for patients suffering from SI joint dysfunction.
  • The LinQ procedure, developed by PainTEQ, represents a major advancement in the treatment of SI joint dysfunction.

Xēnix Medical Receives FDA Clearance of SOLACE™ Sacroiliac Fixation System with NANOACTIV™ Nanotechnology

Retrieved on: 
Tuesday, October 31, 2023
Nanotechnology, Surgery, Health, FDA, Medical Devices, Health Technology, Technology, Other Technology, Food, MD, University of Tennessee Medical Center, Fracture, Regulation of tobacco by the U.S. Food and Drug Administration, Multimedia, Quality of life, Surgeon, University, Immobilization, Stem cell, Consolation, Patient, Sacroiliac joint dysfunction, Navigation, Sacroiliac joint, Medical device

View the full release here: https://www.businesswire.com/news/home/20231031697414/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231031697414/en/
    Xenix Medical SOLACE Sacroiliac Fixation System (Photo: Business Wire)
    The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length.
  • The SOLACE Sacroiliac Fixation System is intended for sacroiliac fusion for sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions; augmenting, immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
  • The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
  • The SOLACE system is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform.

VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations

Retrieved on: 
Tuesday, October 17, 2023
FDA, Health, Surgery, Medical Devices, Surgeon, Laminoplasty, Sacroiliac joint, Food and Drug Administration, Food, Sacroiliac joint dysfunction, New product development, Spine, Patient, Pharmaceutical industry

VySpine , a spine innovation leader using differentiated materials and designs, announced today that it has received a trio of U.S. Food and Drug Administration (FDA) clearances for its products, providing increased diversity to the company’s portfolio.

Key Points: 
  • VySpine , a spine innovation leader using differentiated materials and designs, announced today that it has received a trio of U.S. Food and Drug Administration (FDA) clearances for its products, providing increased diversity to the company’s portfolio.
  • Among the approvals announced is FDA clearance for additional connectors for the VySpan PCT system to add to its versatility.
  • VySpine also received a 510(k) clearance from the FDA for its VyLam System, which is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3-T3) in skeletally mature patients.
  • In addition, the FDA has approved additional indications for VySpine’s VyLink Screw System.

SAIL Fusion Announces First Implantations of its BowTie™ Sacroiliac Fusion System

Retrieved on: 
Monday, October 16, 2023
Medical Devices, Surgery, Hospitals, Neurology, Clinical Trials, Other Health, Biotechnology, Physical Therapy, General Health, Health, Orthopedic surgery, Multimedia, SI, AO, Division, Rehabilitation, Sacroiliac joint dysfunction, Research, Geriatric Orthopaedic Surgery & Rehabilitation, Arthrodesis, Associate, Surgeon, Stroke, TIE fighter, Neurosurgery, SAIL, Rigidity, Patient, Dentistry

SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon AO principles, today announced that it has conducted the first implantations of its novel BowTie SI Fusion System.

Key Points: 
  • SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon AO principles, today announced that it has conducted the first implantations of its novel BowTie SI Fusion System.
  • BowTie is the first SI fusion system to be based on long-standing, proven joint fusion principles established by the AO foundation.
  • I fully expect these patients to do extremely well.”
    Dr. Karimov added, “The BowTie System allowed me to fully access the joint and create an ideal environment for fusion.
  • We look forward to completing our pilot study and launching the product in the United States in the near future.”

Comparative Analysis Concludes Posterior Approach to SI Joint Fusion is as Effective as the Lateral Approach

Retrieved on: 
Wednesday, June 7, 2023
SI, Sacroiliac joint dysfunction, Anesthesiology, LinQ, UCLA Health, MD, Patient, University, University of Kansas Medical Center, Sacroiliac joint, Trauma, Synovial joint, Safety, 3D printing, Dentistry

TAMPA, Fla., June 7, 2023 /PRNewswire/ -- The results of a comparative biomechanical analysis of the posterior sacroiliac (SI) joint fusion to the traditional lateral approach show that a posterior SI joint fusion with LinQ, a novel implant developed by Tampa-based medical device company, PainTEQ, has stabilization results comparable to the lateral approach when put through the same tests.

Key Points: 
  • TAMPA, Fla., June 7, 2023 /PRNewswire/ -- The results of a comparative biomechanical analysis of the posterior sacroiliac (SI) joint fusion to the traditional lateral approach show that a posterior SI joint fusion with LinQ, a novel implant developed by Tampa-based medical device company, PainTEQ , has stabilization results comparable to the lateral approach when put through the same tests.
  • "In a very well-designed, comparative cadaveric, biomechanical study, the authors have demonstrated that LinQ posterior sacroiliac fusion results in superior stabilization of the sacroiliac joint compared to lateral approach instrumentation.
  • This analysis is the first study ever to compare the newer, minimally invasive posterior approach to the lateral method.
  • The study concluded that posterior fusion has similar performance in stabilizing the SI joint during flexion-extension motions and superior performance in stabilizing the SI joint during lateral bending and axial rotation motions compared to the lateral approach (See Figures 1-3).

REGENATIVE LABS ANNOUNCES PUBLICATION OF GROUNDBREAKING PAPER ON WHARTON'S JELLY APPLICATIONS, OPENING THE DOOR FOR EXPANDED TREATMENT OF THE SI JOINT

Retrieved on: 
Thursday, March 9, 2023
Regenerative medicine, Cartilage, Pain management, Supplemental instruction, Case series, Research, Sacroiliac joint, Efficacy, Brace, Patient, Pain, Stiffness, Cryopreservation, Durability, Sacroiliac joint dysfunction, SI, WOMAC, Dentistry

Written by a team of translational experts, this paper provides a comprehensive analysis of the role of Wharton's Jelly applications in supplementing tissue issues within the refractory sacroiliac (SI) joint in 38 patients.

Key Points: 
  • Written by a team of translational experts, this paper provides a comprehensive analysis of the role of Wharton's Jelly applications in supplementing tissue issues within the refractory sacroiliac (SI) joint in 38 patients.
  • This data comes at an opportune time, as the current standard of care for SI joint pain only addresses the symptoms, using methods such as pain medication, braces, or SI fusion.
  • Statistically significant improvements in NPRS and WOMAC scores of the affected SI joint were reported after 90 days.
  • "We are delighted to see this important research published," said Tyler Barret, CEO of Regenative Labs.

VYRSA Technologies Announces Worldwide Launch of the VYRSA V1™ SI Fusion System

Retrieved on: 
Friday, December 2, 2022
SI, MIS, SIJ, Sacroiliac joint dysfunction, Sacroiliac joint, FDA, Pain, Federal Food, Drug, and Cosmetic Act, Patient, Ilium, Environment, Control, Anatomy, 3D, Sacrum, Medical device, Test

KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ -- VYRSA Technologies, a specialty medical device firm, announced today the FDA clearance of the VYRSA V1™ SI Fusion System. After an extensive two 1/2-year biomechanical testing protocol, VYRSA Technologies submitted a comprehensive data set to the FDA showing overwhelming evidence of biomechanical stability in the sacroiliac joint after implantation of the VYRSA V1™ SI Fusion System.

Key Points: 
  • KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ -- VYRSA Technologies, a specialty medical device firm, announced today the FDA clearance of the VYRSA V1 SI Fusion System.
  • After an extensive two 1/2-year biomechanical testing protocol, VYRSA Technologies submitted a comprehensive data set to the FDA showing overwhelming evidence of biomechanical stability in the sacroiliac joint after implantation of the VYRSA V1 SI Fusion System.
  • VYRSA V1 has multiple openings to allow a large volume of autogenous bone graft to be easily packed into the implant to facilitate fusion.
  • With an innovative portfolio of MIS allograft implants and innovative transfixing medical devices, VYRSA Technologies is uniquely positioned as an industry leader in sacroiliac fusion.

PainTEQ Expands Leadership Team with New Senior VP of Reimbursement and Market Access

Retrieved on: 
Friday, December 2, 2022
Strategic planning, Pain management, LinQ, SI, SIJ, Economics, Health, Boston Scientific, Senior, SVP, Sacroiliac joint dysfunction, Patient, Chronic pain, Multimedia, Physician, Health insurance

TAMPA, Fla., Dec. 2, 2022 /PRNewswire/ -- PainTEQ, a fast-growing medical innovation company and the creator of LinQ, a minimally invasive therapy for SI joint (SIJ) dysfunction, announced the appointment of Michael Mydra as its new Senior Vice President (SVP) of Reimbursement & Market Access.

Key Points: 
  • In his new role, Michael will be responsible for expanding patient access to the LinQ procedure through reimbursement and market access.
  • "Michael's extensive experience in healthcare reimbursement, strategic planning and business development is invaluable to PainTEQ," said Sean LaNeve, PainTEQ's CEO.
  • "We are confident he is the right person to lead our efforts in expanding patient access to LinQ."
  • "I am very fortunate to have the opportunity to join the PainTEQ team," Michael stated.

Aurora Spine Corporation Announces FDA 510(k) Clearance for its SiLO TFX™ MIS Sacroiliac Joint Fixation System

Retrieved on: 
Thursday, October 6, 2022
Aurora, ASG, News, Silo, Titanium, Growth, Sacrum, Patient, Back pain, Sacroiliac joint dysfunction, Investment, Risk, SI, University, TSX Venture Exchange, Spine, United, Awareness, GLOBE, Joint, Sacroiliac joint, FDA, Solution, TFX, Ilium, Medical device

CARLSBAD, Calif., Oct. 06, 2022 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the patented minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System.

Key Points: 
  • CARLSBAD, Calif., Oct. 06, 2022 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the patented minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System.
  • The Aurora Spine SiLO TFX MIS Sacroiliac Joint Fixation System, is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
  • The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation.
  • "The SiLO TFX clearance is an essential milestone for Aurora Spine as they are committed to helping patients experiencing chronic SI Joint pain."

SI-BONE, Inc. Announces FDA Clearance for Expanded Indication of the iFuse-TORQ® Implant System

Retrieved on: 
Monday, June 13, 2022
Fracture, Pelvic fracture, Sacroiliac joint dysfunction, SI, Lists of diseases, Silicon, CEO, Medicare, Nasdaq, Stanford University Medical Center, FDA, GLOBE, Patient, Publication, Anatomy, MD, Injury, Surgeon, Pelvis, All rights reserved, Adhesive, Dentistry

* Fractures covered in this clearance include pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures.

Key Points: 
  • * Fractures covered in this clearance include pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures.
  • The strength and osseointegrative features of iFuse-TORQ make it the most attractive implant on the market to remobilize these osteoporotic patients.
  • 2012 Jun; 13(2): 97103
    SI-BONEis a global technological leader for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy.
  • * The newly cleared indication statement is:
    The iFuse-TORQ Implant System is indicated for:
    Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures
    SI-BONE, iFuse Implant System, iFuse-TORQ, Bedrock, and Bedrock Granite are registered trademarks of SI-BONE, Inc. 2022 SI-BONE, Inc. All Rights Reserved.