Sacroiliac joint

Inspired Spine announces Trident™ SI Joint Screw System Secures FDA 510(k) Approval

Retrieved on: 
Tuesday, January 26, 2021
Pelvis, Joints, Sacroiliac joint, Sacrum, Screw, Si, Branches of biology

BURNSVILLE, Minn., Jan. 26, 2021 /PRNewswire/ --Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM), has secured FDA 510(k) marketing clearance.

Key Points: 
  • BURNSVILLE, Minn., Jan. 26, 2021 /PRNewswire/ --Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM), has secured FDA 510(k) marketing clearance.
  • "We continue to raise the standard of care for back pain treatment as this SI Joint fusion technique represents another Inspired Spine breakthrough for surgeons and patients alike," stated Inspired Spine CMO Dr.Hamid Abbasi.
  • Inspired Spine's surgeons have recently developed the Trident Sacroiliac Joint Fusion System (Patent Pending) which will significantly improve procedure efficiency resulting in surgery durations less than 15 minutes.
  • This new SI Joint fusion system employs one main screw and two (2) integrated side screws to deliver three distinct screw approaches into a single trajectory.

Sacrix Launches Its New Percutaneous Platform For Sacroiliac Joint Fixation

Retrieved on: 
Sunday, January 24, 2021
Musculoskeletal system, Anatomy, Pelvis, Joints, Sacroiliac joint, Sacrum, Sacroiliitis, Self-tapping screw, Sacroiliac joint pain

This new design can be described as a screw and cage hybrid with 3 different thread combinations that is self-drilling, self-tapping and compresses across the Sacroiliac joint.

Key Points: 
  • This new design can be described as a screw and cage hybrid with 3 different thread combinations that is self-drilling, self-tapping and compresses across the Sacroiliac joint.
  • The instrumentation is now simplified to allow for a 2-step technique with a 1.5cm incision, 100% percutaneous under fluoroscopy and bloodless.
  • These updates will enhance the user experience, while offering a safe, effective and simple solution to Sacroiliac Joint dysfunction."
  • Sacrix is a KICVentures Group portfolio company focused on revolutionary percutaneous posterior sacroiliac fixation technologies for the treatment of sacroiliac dysfunction and sacroiliitis.

SI-BONE, Inc. Announces that Updated ISASS Policy and Guidelines on MIS SI Joint Fusion Support Only Lateral Transiliac MIS Procedures

Retrieved on: 
Monday, January 4, 2021
Pelvis, Joints, Sacroiliac joint, Sacrum, Bone fracture, Sacroiliac joint dysfunction

The policy and guidelines remain supportive of continued adoption of MIS SI joint fusion procedures by the clinician and payor communities, limited to procedures using a lateral transiliac approach, which includes the iFuse Procedure.

Key Points: 
  • The policy and guidelines remain supportive of continued adoption of MIS SI joint fusion procedures by the clinician and payor communities, limited to procedures using a lateral transiliac approach, which includes the iFuse Procedure.
  • ISASS does not recommend MIS posterior (dorsal) SI joint fusion procedures, whether using an implantable device or a product such as bone allograft.
  • The ISASS policy states that the high-level clinical and safety data from evaluation of MIS lateral transiliac SI joint fusion devices such as iFuse are likely not generalizable to these posterior (dorsal) MIS SIJF procedures.
  • In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

SI-BONE, Inc. Announces that Priority Health Became the 36th Payor with Exclusive iFuse Coverage Policy

Retrieved on: 
Monday, December 21, 2020
Healthcare reform in the United States, Federal assistance in the United States, Presidency of Lyndon B. Johnson, Managed care, Pelvis, Medicaid, Medicare, Sacroiliac joint, Health, United States

Prior to its November 2020 update, the Priority Health policy covered sacroiliac (SI) joint fusion without a requirement that any particular implant be used.

Key Points: 
  • Prior to its November 2020 update, the Priority Health policy covered sacroiliac (SI) joint fusion without a requirement that any particular implant be used.
  • MIS SI joint fusion will remain experimental and/or investigational for all other systems and approaches, including cylindrical threaded implants.
  • Priority Health is the second largest health plan in the state of Michigan, with more than 780,000 covered lives.
  • Priority Health has enrollees in commercial, Medicare Advantage, and Medicaid health plans it operates.

SI-BONE, Inc. Announces that Humana Establishes Exclusive Coverage for iFuse in MIS SI Joint Fusion Procedures

Retrieved on: 
Wednesday, December 16, 2020
Medicine, Branches of biology, Pelvis, Prosthetics, Clinical medicine, Joints, Sacroiliac joint, Sacrum, Implant, Cigna, Aetna, Minimally invasive procedure

With this updated policy, Humana joins 36 other health plans that cover MIS SI joint fusion using the iFuse Implant System exclusively, as well as other large payors including United Healthcare, CIGNA and Aetna, which also provide positive coverage for iFuse procedures.

Key Points: 
  • With this updated policy, Humana joins 36 other health plans that cover MIS SI joint fusion using the iFuse Implant System exclusively, as well as other large payors including United Healthcare, CIGNA and Aetna, which also provide positive coverage for iFuse procedures.
  • SI-BONE is a medical device company that pioneered minimally invasive surgery of the SI joint with the iFuse Implant System.
  • This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.
  • In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

SI-BONE, Inc. to Host Virtual KOL Surgeon Panel at NASS

Retrieved on: 
Thursday, October 1, 2020
Anatomy, Musculoskeletal system, Branches of biology, Human back, Pain, Pelvis, Prosthetics, Sacroiliac joint, Sacrum, Bone fracture, Implant, Low back pain

Studies have shown that the SI joint can be a source of pain in 15% to 30% of chronic low back pain.

Key Points: 
  • Studies have shown that the SI joint can be a source of pain in 15% to 30% of chronic low back pain.
  • There are over 85 peer-reviewed publications demonstrating the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse Implant ( www.si-bone.com/results ).
  • In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
  • SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. 2020 SI-BONE, Inc. All Rights Reserved.

Captiva Spine Granted New Patent in the U.S. for Unique Approach to Site Preparation for Posterior SI Joint Fusion Surgery

Retrieved on: 
Thursday, October 1, 2020
Pelvis, Joints, Sacroiliac joint, Sacrum, Captiva

Specifically, the system's precision form of Quadracentric carpentry which prepares the sacroiliac joint (SI) intended for an easy, safe, and repeatable SI joint fusion surgery.

Key Points: 
  • Specifically, the system's precision form of Quadracentric carpentry which prepares the sacroiliac joint (SI) intended for an easy, safe, and repeatable SI joint fusion surgery.
  • This patent marks another milestone for Captiva Spine's growing patent portfolio," said Dale Mitchell, President of Captiva Spine.
  • "TransFasten's form of carpentry is truly aligned with key principles of achieving ease of use, stabilization, and fusion while utilizing a safe posterior approach."
  • "As Captiva Spine continues to introduce TransFasten, many will bring this procedure to their practice simply for the safety of the posterior approach coupled with this unique approach to SI joint fusion site preparation," said Dr. Robert E. Lins, The Center for the Bone & Joint Surgery, and inventor of TransFasten.

Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology

Retrieved on: 
Thursday, October 1, 2020
Biotechnology, Physical therapy, Technology, FDA, Other Health, Health, Other Technology, Medical devices, Surgery, Nanotechnology, Hardware, Pelvis, Joints, Sacroiliac joint, Sacrum, Si, Firebird, Software, Computing

(NASDAQ:OFIX), a global medical device and biologics company with a spine and extremities focus, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the nanotechnology feature of the FIREBIRD SI Fusion System .

Key Points: 
  • (NASDAQ:OFIX), a global medical device and biologics company with a spine and extremities focus, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the nanotechnology feature of the FIREBIRD SI Fusion System .
  • Introduced earlier this year, the FIREBIRD SI Fusion System is the first 3D-printed titanium bone screw with nanotechnology specifically designed to compress and stabilize the sacroiliac joint (SI joint) during fusion.
  • View the full release here: https://www.businesswire.com/news/home/20201001005392/en/
    Illustration of the Orthofix FIREBIRD SI Fusion System with NANOVATE technology (Photo: Business Wire)
    The FIREBIRD SI Fusion System with NANOVATE technology is one of the many new differentiated solutions that Orthofix is proud to highlight during the upcoming North American Spine Society (NASS) 2020 virtual annual meeting, said Kevin Kenny, Global President of Orthofix Spine.
  • The FIREBIRD SI Fusion System is implanted through a minimally invasive procedure that involves inserting two to four bone screws across the SI joint to stabilize the joint during the fusion process.

Life Spine Announces FDA 510(k) Clearance for SI Joint Revision Offering and Additional Claims for the SImpact® Sacroiliac Joint Fixation System

Retrieved on: 
Tuesday, September 22, 2020
Biotechnology, Physical therapy, Surgery, General Health, Health, FDA, Medical devices, Hospitals, Prosthetics, Pelvis, Joints, Sacroiliac joint, Sacrum, Implant, Fixation, Branches of biology, Medical technology, Medicine

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a SI revision offering and additional claims for the SImpact Sacroiliac Joint Fixation System.

Key Points: 
  • Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a SI revision offering and additional claims for the SImpact Sacroiliac Joint Fixation System.
  • The new clearance adds a 14.5mm diameter screw to Life Spines SI fixation portfolio.
  • The large diameter of the SImpact Revision implant allows one to fill the bone void while supplying immediate fixation to the site.
  • I have performed numerous SI fixation procedures with many different implants and SImpact is the most appealing system on the market.

SI-BONE, Inc. Announces Exclusive, Positive iFuse Coverage decision by Medica

Retrieved on: 
Tuesday, August 25, 2020
Medicine, Medical specialties, Anatomy, Pelvis, Prosthetics, Joints, Sacroiliac joint, Sacrum, Minimally invasive procedure, Implant, Surgery, Sacroiliac joint dysfunction

Under the revised coverage policy, minimally invasive SI joint fusion is now covered for the treatment of moderate-to-severe SI joint pain exclusively when the iFuse Implant System is used.

Key Points: 
  • Under the revised coverage policy, minimally invasive SI joint fusion is now covered for the treatment of moderate-to-severe SI joint pain exclusively when the iFuse Implant System is used.
  • With the addition of Medica, there are now thirty-five U.S. commercial payers that cover SI joint fusion procedures only when iFuse is used.
  • SI-BONE is a medical device company that pioneered minimally invasive surgery of the SI joint with the iFuse Implant System.
  • In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.