Sacroiliac joint

PainTEQ Receives Two New Patents for the LinQ Procedure, Advancing Treatments for SI Joint Dysfunction

Retrieved on: 
Thursday, May 2, 2024

These patents mark a notable step forward in medical device innovation, offering new hope to thousands suffering from debilitating lower back pain.

Key Points: 
  • These patents mark a notable step forward in medical device innovation, offering new hope to thousands suffering from debilitating lower back pain.
  • "With these two new patents plus the three patents granted in 2023, PainTEQ now boasts a total of 14 patents.
  • This portfolio underscores PainTEQ's commitment to advancing treatments for sacroiliac joint pain," said Sean LaNeve, CEO of PainTEQ.
  • US patent number 11,963,883 (April 23, 2024) relates to the design of the LinQ allograft implant for the sacroiliac joint.

Spinal Simplicity announces FDA 510(k) Clearance of its Sacroiliac Joint System, the Patriot-SI Posterior Implant, With a Unique Hybrid Indication for Use

Retrieved on: 
Wednesday, May 1, 2024

OVERLAND PARK, Kan., May 1, 2024 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the Food and Drug Administration (FDA) 510(k) clearance of the Patriot-SI Posterior Implant System as part of a hybrid SI joint fusion construct to be used in conjunction with the Liberty-SI lateral transfixing system. The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis. When the Patriot-SI System (i.e., an "in-line" or "intra-articular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

Key Points: 
  • Spinal Simplicity announced the FDA 510(k) clearance of its Patriot-SI Posterior Implant System, designed for sacroiliac joint fusion in combination with the Liberty-SI lateral system.
  • This clearance introduces a hybrid SI joint fusion construct, offering new treatment options for conditions such as sacroiliac disruptions and degenerative sacroiliitis.
  • The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
  • "This announcement today marks a second product milestone in the past five months for Spinal Simplicity," said CEO Todd Moseley .

Captiva Spine Introduces TransFasten® LSF, Lateral SI Fusion System, Creating a Comprehensive Selection of ASC-Ready SI Fusion Solutions

Retrieved on: 
Tuesday, April 2, 2024

JUPITER, Fla., April 2, 2024 /PRNewswire-PRWeb/ -- TransFasten® LSF Lateral SI Fusion System: Elevating Minimally Invasive Sacroiliac Joint Surgery

Key Points: 
  • Captiva Spine®, a medical technology organization connecting healthcare professionals, distribution specialists, and healthcare facilities with cutting-edge spinal care technology, announces the launch of the TransFasten-LSF Lateral SI (Sacroiliac) Fusion System.
  • The addition of this system marks a significant advancement that builds upon the TransFasten® SI fusion product line, adding ASC-READY flexibility for healthcare providers treating SI joint dysfunction.
  • The TransFasten-LSF Lateral SI Fusion System features:
    A fully threaded, self-drilling/self-tapping bone screw with a unique design optimized for surgical efficiency and patient outcomes.
  • President of Captiva Spine, Dale Mitchell , said, "The ASC-READY TransFasten-LSF system is designed to simplify the lateral SI fusion process, potentially shortening operating times and reducing procedural complexity.

AURORA SPINE ANNOUNCES ATTENDANCE AT NORTH AMERICAN NEUROMODULATION SOCIETY (NANS) ANNUAL MEETING

Retrieved on: 
Thursday, January 18, 2024

CARLSBAD, Calif., Jan. 18, 2024 (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 that it will be participating in the North American Neuromodulation Society (“NANS”) Annual Meeting from January 18-21 in Las Vegas, Nevada.

Key Points: 
  • CARLSBAD, Calif., Jan. 18, 2024 (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 that it will be participating in the North American Neuromodulation Society (“NANS”) Annual Meeting from January 18-21 in Las Vegas, Nevada.
  • The NANS Annual Meeting is a prominent medical conference that brings together healthcare professionals, researchers, and experts in the field of neuromodulation.
  • Aurora will be showcasing two Sacroiliac Joint (SI Joint) fusion products.
  • Silo TFX and Silo offer physicians options to stabilize the SI Joint, helping patients with access to treatment for their SI joint dysfunction.

Omnia challenges PainTEQ Intellectual Property

Retrieved on: 
Tuesday, January 9, 2024

In other words, the PTAB decided it would allow Omnia Medical's Petition for inter parties review of PainTEQ patent "11,020,129 B2 Drill-less Method of Fusing a Sacroiliac Joint" to proceed, finding that there is reasonable likelihood that challenged claims 1, 2, 9, and 10 in the PaintTEQ patent, U.S. 11,020,129, (the '129 patent) are invalid in view of the grounds presented in Omnia Medical's petition.

Key Points: 
  • In other words, the PTAB decided it would allow Omnia Medical's Petition for inter parties review of PainTEQ patent "11,020,129 B2 Drill-less Method of Fusing a Sacroiliac Joint" to proceed, finding that there is reasonable likelihood that challenged claims 1, 2, 9, and 10 in the PaintTEQ patent, U.S. 11,020,129, (the '129 patent) are invalid in view of the grounds presented in Omnia Medical's petition.
  • "We are pleased with the PTAB's decision and look forward to the final resolution of this petition.
  • As is evidenced by our existing and expanding patent portfolio and resulting consolidated Federal Courts cases with PainTEQ, we take Intellectual Property rights very seriously."
  • said Troy Schifano, CEO of Omnia Medical.

Sacrix Provides Safe Alternative to Risky Revision Spine Surgery, Publishing Groundbreaking Results in Renowned Spine Journal

Retrieved on: 
Sunday, January 7, 2024

BURLINGTON, Mass., Jan. 6, 2024 /PRNewswire-PRWeb/ -- The article, titled "Salvage of failed direct lateral sacroiliac joint fixation using a new percutaneous lateral-oblique transfixation technique with two variable-threaded screws," promises to redefine the realm of sacroiliac joint surgeries.

Key Points: 
  • Sacrix, a pioneer medical device company in outpatient spine surgery solutions, proudly unveils a novel Less Exposure Spine Surgery (LESS) technique that helped patients avoid major and risky revision corrective spine surgery.
  • The clinical results were summarized in a research paper authored by Board-certified Orthopedic Spine surgeons and published through a premiere peer-reviewed scientific clinical journal.
  • Dr. Richard Francis, a pioneering spine surgeon in Houston, Texas, stated, "the Sacrix technique and device is the best option for this problem."
  • The Sacrix technique offers immediate stability and documented long-term fusion, marking a significant advancement in outpatient orthopedic spine surgery.

Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant

Retrieved on: 
Monday, December 11, 2023

OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion system. The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.

Key Points: 
  • Spinal Simplicity's Liberty-SI Lateral Implant System is a revolutionary sacroiliac joint fusion technology designed for safer and potentially less invasive treatment of sacroiliac disruptions and degenerative sacroiliitis.
  • OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System ; a transfixing, lateral sacroiliac (SI) joint fusion system.
  • The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
  • The lateral surgical technique first decorticates the bone, preparing the joint for fusion.The Liberty-SI implant is designed to achieve arthrodesis of the SI joint using a lateral technique that passes through the ilium across the sacroiliac joint and into the sacrum, thus transfixing the sacroiliac joint.

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

Retrieved on: 
Tuesday, October 31, 2023

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

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.

AMA Introduces New Category I CPT Code 27278 for Posterior SI Joint Fusion

Retrieved on: 
Tuesday, October 17, 2023

TAMPA, Fla., Oct. 17, 2023 /PRNewswire/ -- The American Medical Association (AMA) has announced the release of the 2024 CPT code set, which includes a new Category I CPT code for PainTEQ's LinQ SI Joint Stabilization procedure. The new code, effective as of January 1, 2024, is 27278.

Key Points: 
  • TAMPA, Fla., Oct. 17, 2023 /PRNewswire/ -- The American Medical Association (AMA) has announced the release of the 2024 CPT code set, which includes a new Category I CPT code for PainTEQ 's LinQ SI Joint Stabilization procedure.
  • The detailed description of the new code is:
    27278 Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra-articular implant(s) (e.g.
  • Michael Mydra, Senior Vice President, Reimbursement and Market Access at PainTEQ, expressed his enthusiasm about the new code, stating, "The inclusion of the LinQ SI Joint Stabilization procedure as a Category I CPT code is a major milestone for PainTEQ, physicians performing the procedure, and patients suffering from SI Joint pain.
  • The assignment of this new CPT code is a testament to the efficacy and importance of the LinQ procedure.