SpineGuard – Real-time monitoring solutions

Vision

Pierre Jérôme and Stéphane Bette founded SpineGuard in 2009 with the idea of delivering the clinical benefits of the DSG® (Dynamic Surgical Guidance) technology to as many patients as possible. SpineGuard’s primary goal is to establish the DSG technology as a standard of care to SECURE AND STREAMLINE SKELETAL IMPLANT PLACEMENT for the benefit of patients, surgeons, operating room staff, healthcare providers and SpineGuard’s shareholders.

Technology

DSG is a powerful radiation-free real time sensing technology platform that was co-invented by Professor Ciaran Bolger, MD PhD, Maurice Bourlion, PhD, and Alain Vanquaethem. The PediGuard devices, which incorporate the DSG Technology, were the first handheld devices capable of alerting surgeons in real time of potential vertebral cortical wall breaches. Fourteen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits of DSG® Technology. Building on these solid fundamentals and several strategic partnerships, SpineGuard has expanded its technology platform into disruptive innovations: the «smart» pedicle screw launched, in late 2017, in dental implantology and is broadening the scope of applications to surgical robotics.

Mission

SpineGuard’s mission is to help surgeons MAKE SPINE SURGERY SAFER while deploying and driving adoption of smart devices derived from its DSG platform for spine surgery and other skeletal applications in partnership with innovative medical device companies.

Approach

A dedicated, cohesive and international team with an ambitious vision, a clear mission, financial discipline and a well-defined roadmap towards the future. SpineGuard’s corporate headquarters are located in Vincennes, near Paris, France. The company also has an office in Boulder, Colorado, USA focused on sales and marketing to support the technology and the products in the US market. SpineGuard is listed on Euronext-Growth Paris (ALSGD) since 2013.

SpineGuard is committed to a CSR (Corporate Social Responsibility) approach with the voluntary involvement of the whole team.

Quality Policy

Quality is at the heart of SpineGuard’s expertise. We are proud to maintain and continuously improve a quality system that complies with international standards, such as ISO13485, 21 CFR Part 820 in the USA, MHLW Order No. 169 as amended by MHLW Order No. 87/2014 in JAPAN, or RDC 16 and Ordinance 384 in Brazil.
Today our products are registered in more than 30 countries worldwide, in addition to being CE marked and approved by the Food and Drug Administration (FDA).

SpineGuard offers you the following real-time monitoring solutions:

1. Straight PediGuard – Real-time, one-piece (one-piece, compact) pedicle guidance tool

Main Features

  • Straight tip
  • Available in 3 different diameters: Ø2.5 mm, Ø3.2 mm and Ø4.0 mm
  • Assist surgeons in preparing the pedicle for screw placement at any level of the spine
  • CE marked and FDA cleared
SPINE GUARD CLASSIC

2. Curved PediGuard – Real-time, one-piece (one-piece, compact) pedicle guidance tool

Main Features

  • Curved tip
  • 2 different diameters: Ø3.6 mm and Ø4.0 mm
  • Ease penetration through the pedicle and removal thanks to the tapered tip
  • Ease redirection during pedicle drilling: as surgeons become comfortable with the direction of the curve, they can be aware of the location of a possible breach, and hence allow proper redirection
  • Mainly used in thoracic and lumbar, especially for deformity
  • CE marked and FDA cleared
PEDIGUARD XS CURVED

3. Cannulated PediGuard – Real-time monitoring device

Main Features

  • 2 types of tips (bevel and trocar)
  • Needle available in 2 sizes (120mm and 160mm) – the longest PediGuard instrument/shaft
  • Progressive diameter of the Needle to ease the insertion and removal
  • Graduated shaft to control the progression into the bone
  • Designed primarily for helping surgeons reduce radiation exposure during minimally-invasive procedures
  • Can also be used to access and drill narrow and small pedicles
  • CE marked and FDA cleared
Dispozitiv de monitorizare  in timp real - PediGuard (Canulat)
Dispozitiv de monitorizare  in timp real - PediGuard (Canulat)
Dispozitiv de monitorizare  in timp real - PediGuard (Canulat)

4. Threaded PediGuard – Real-time monitoring device

Main Features

  • Threaded tip
  • Design available in three diameters: Ø4.0mm, Ø4.5mm and Ø5.5mm (other diameters are available, please contact SpineGuard for more information)
  • Stiff drilling instrument that may be used to streamline surgical steps while maintaining the accuracy for pedicle preparation for screw placement
  • Potential reduction of the use of intraoperative imaging in standard and MIS procedures
  • CE marked and FDA cleared for posterior pedicle screw drillings
  • FDA cleared for vertebral body drillings by anterior approach

Other solutions offered by SpineGuard:

  • Real-time monitoring device used in Dental Implantology
  • Real-time monitoring device used in Orthopedics

For more information see the official site SpineGuard>>

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