• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » 3Spine wins FDA IDE for spine implant

3Spine wins FDA IDE for spine implant

June 22, 2022 By Sean Whooley

3spine MOTUS
[Image from 3Spine]
3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device.

Chattanooga, Tennessee-based 3Spine designed the Motus device for use in the BalancedBack total joint replacement procedure.

3Spine’s BalancedBack procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level.

The first-of-its-kind Motus technology replaces the function of the disc and facet joints through a posterior approach, broadly addressing leg pain, back pain and spinal instability while correcting posture and restoring freedom of movement through the reconstruction of the functional spinal unit.

Motus received FDA breakthrough device designation in 2020, according to a news release.

“Breakthrough device designation was critical to our success in the IDE approval process,” 3Spine CEO Ron Yarbrough said in the release. “This project is the culmination of decades of technical and clinical research in the lumbar spine, and while the courage of pioneering patients and surgeons brought us to this point, today it is all about the tenacity and expertise of the FDA review team.

“Our interactive review with FDA over the past two years has resulted in comprehensive coverage of an unparalleled number of technical disciplines, reflecting the potentially transformational nature of this spine technology. We are very excited to begin IDE enrollment.”

3Spine will conduct a U.S. pivotal clinical trial for Motus, having previously completed contracting and site initiation at 16 U.S. centers for a prospective real-world evidence fusion study that has been enrolling patients since May 2021.

As sites complete the enrollment for their real-world evidence cohort, each center becomes eligible to participate in the IDE study, which will enroll approximately 150 real-world patients to propensity match with approximately 150 IDE patients in an adaptive statistical design.

MCRA has supported 3Spine through the study design and IDE approval processes, the company said.

“This is important, breakthrough technology for an underserved patient population,” said Justin Eggleton, Vice President of Spine Regulatory Affairs at MCRA. “The considerations for such a novel treatment required significant resources at FDA, and we appreciate the agency’s dedication to the review. The FDA review team carefully and thoughtfully challenged over 10,000 pages of biomechanical data, clinical history, and an exhaustive battery of non-clinical testing. FDA’s review establishes an important foundation for our project. MCRA is excited to partner with 3Spine as CRO for the IDE to strengthen the safety and effectiveness profile for our future pre-market approval application.”

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: 3Spine

In case you missed it

  • They said it at DeviceTalks Boston
  • Elucid raises $27M for heart disease diagnosis software
  • Summer health technology program brings diverse group of interns to Silicon Valley
  • BioSig expects to raise $3.5M from public offering
  • Haemonetics completes move to new Pennsylvania manufacturing facility
  • Vivera adds two industry veterans to its technology advisory board
  • Abbott Fund grants $750k to education, health equity program
  • Another Medtronic HVAD recall is serious
  • Endologix reports positive results from percutaneous bypass trial
  • NorthStar Medical names new president and chief operating officer
  • Vektor Medical names Rob Krummen as CEO
  • Baxter’s Volara lung therapy system recall is Class I
  • BD voluntarily recalls intraosseous products
  • Bioventus restructures $315M CartiHeal acquisition
  • Intrommune extends scope of Phase 1 trial for peanut-allergy-treating toothpaste
  • How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
  • Hamilton Medical warns on some ventilators

RSS From Medical Design & Outsourcing

  • They said it at DeviceTalks Boston
    Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat… […]
  • Summer health technology program brings diverse group of interns to Silicon Valley
    Diversity by Doing HealthTech (DxD) is holding a Summer Innovation and Exploration Series for college student interns from underrepresented groups. The series is on its second day today at Fogarty Innovation and Stanford Byers Center for Biodesign — the two organizations that jointly formed and support DxD. The event debuted last year in an online… […]
  • Clippard releases new series of isolation valves
    Clippard (Cincinnati) has Its Clippard NIV Series media isolation valve — a solenoid-operated device using a flexible diaphragm to isolate the actuation mechanism from the fluid path. Media isolation valves find everyday use in a wide variety of applications. Think uses that require precise, repeatable dispensing of media for analytical instrumentation. Clippard says media isolation… […]
  • Another Medtronic HVAD recall is serious
    A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this… […]
  • How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
    SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff… […]
  • How Avail Medsystems seeks to create a connected OR experience
    Much like a normal Starbucks-goer expects the coffee to taste a certain way at any location, Daniel Hawkins wants that type of experience in the operating room. Hawkins is the CEO of Avail Medsystems, a company developing telemedicine equipment that can connect surgeons, interventional specialists and medical device sales reps. Hawkins and the team at Avail… […]
  • How to leverage technology to drive diversity in clinical studies
    Convenience was the driver, and the traditional clinical trial model had to evolve when it came to a colorectal cancer screening study. The clinical study had 35,000 patients across the U.S. Chuanbo Xu, Freenome Cancer doesn’t discriminate. It’s the second-leading cause of death in the U.S. Early detection is key in treating — and even… […]
  • Medical device licensing pitfalls to avoid
    Prevent costly disputes caused by these common mistakes in patent license agreements. Marcelo Barros, Kathleen Daley, Brian Kacedon and Matthew Ritter, Finnegan Licensing and other technology transfer agreements can be critical for medical device companies that invest significantly into new technology R&D and seek and obtain intellectual property protection for those investments. But if these agreements… […]
  • Tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices
    Tolerance stack-up is a defining design concept to ensure new products are built efficiently and effectively.  Darren Gilmer, Intricon At a time when the future of micro-miniature medical devices seems unlimited, one fundamental reality remains firmly in place — the sizes and shapes of human anatomy. From blood vessels to ear canals, respiratory passages to… […]
  • Deburring and finishing for beautiful, functional medical devices
    The latest automated cutting tools help medical device manufacturers meet strict specs and high demand. Dave Sawicki, Xebec Increasing demand and advances in technology are driving growth in the medical device industry. Chronic diseases are more prevalent, and the aging population is larger, contributing to the demand for highly regulated Class III medical devices such… […]
  • FDA seeking innovations to move beyond heater-cooler device problems
    The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices. According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm… […]

Primary Sidebar

DeviceTalks Weekly

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS