Frequently Asked Questions

Find answers to commonly asked questions regarding our company,
and both OmniGuide Surgical and Domain Surgical products.

OmniGuide – the Company

What is OmniGuide?

OmniGuide designs and manufactures advanced energy surgical systems that deliver energy in a safe, contained manner resulting in the preservation of healthy tissue. We focus on developing CO2 lasers, enhanced safety fibers, and ferromagnetic surgical technologies which are used in a variety of complex surgical procedures.

When was the company formed, and where is it located?

In 1998, a group of researchers at the Massachusetts Institute of Technology (MIT) revealed a simple solution to a seemingly impossible problem – how to reflect and channel CO2 laser energy through a hollow-core flexible fiber. Their work was cited in Science Magazine’s “Breakthrough of the Year” feature in 1999, placing second only to the Human Genome Project. In 2000, OmniGuide Surgical, Inc. was formed and since then has expanded into numerous specialties including Otolaryngology, Otology, Gynecology and Neurosurgery. Today, OmniGuide is based in Lexington, MA USA and remains committed to patient safety by continuously innovating our core technology to deliver advanced surgical solutions for surgeons and their patients.

Domain Surgical was formed in 2011, when technology for a novel ferromagnetic surgical system was licensed from pediatric neurosurgeon Kim H. Manwaring, M.D. Dr. Manwaring originally conceived the technology as a better alternative to existing energy-based surgical modalities. Since that time, Domain Surgical’s ferromagnetic technology has been used in many surgical specialties including Cardiothoracic, Head & Neck, Neurosurgery, Surgical Oncology, and more. Domain Surgical is based in Salt Lake City, UT USA.

In August of 2016, OmniGuide Holdings, Inc. the parent company of OmniGuide Surgical, merged with Domain Surgical.

Where are OmniGuide products sold?

OmniGuide has a global presence serving the United States and many other countries across the world. OmnGuide currently distributes its products in the following countries:

  • Australia
  • Austria
  • Benelux
  • Denmark
  • Finland
  • Germany
  • Ireland
  • Italy
  • Japan
  • Malaysia
  • New Zealand
  • Saudi Arabia
  • Singapore
  • Switzerland
  • Thailand
  • Turkey
  • United Arab Emirates
  • United Kingdom
  • United States
  • Vietnam

For additional international distribution information, please contact international@omni-guide.com.

What are the reimbursement codes for your products?

OmniGuide products are currently covered under the global payment fee for the procedure. There are no separate DRG or CPT codes for reimbursement.

CO2 Laser Technology

How does CO2 laser technology work?

CO2 laser energy is highly absorbed in water. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization and coagulation of soft tissue with micron-level impact to surrounding tissues. Learn more about how CO2 laser energy works here.

Are CO2 lasers cleared by the FDA?

Yes. The CO2 lasers and flexible fibers have all received 510(k) clearances from the FDA. Regulatory documents for the CO2 laser system can be seen in our Download Library.

Why do surgeons choose CO2 energy in their practice?

The most compelling application of this breakthrough is its use to treat patients with afflictions ranging from Head & Neck cancer to infertility. CO2 laser energy has long been considered the gold standard for safety and precision due to its precise interaction with tissue. This energy is highly absorbed in water (the main component of living cells), allowing it to efficiently vaporize tissue. Efficient vaporization results in minimal thermal spread and reduced injury to surrounding healthy tissue. Prior to the release of OmniGuide’s revolutionary fiber technology, CO2 energy could only be delivered through large, cumbersome line-of-sight laser, which limited its use to only a few clinical treatments.

Which flexible fibers are compatible with which instrumentation?

A fiber compatibility chart has been created to identify which fibers can be used in the various instrumentation configuration. Click here to view the fiber compatibility chart.

FMX Ferromagnetic Technology

What is FMX ferromagnetic technology?

The FMX Ferromagnetic Surgical System was designed by Domain Surgical, which is now part of OmniGuide. The FMX system is an intelligent surgical platform that uses ferromagnetic technology to precisely cut, coagulate, and seal tissue; with a fraction of tissue injury compared to other surgical technologies, and without passing electrical current through the patient. Simply described, localized heat is produced when a material having magnetic “domains” is exposed to an alternating magnetic field. This heat is used to cut, coagulate, and seal tissue. Learn more about how ferromagnetic technology works here.

What is the energy source for the FMX technology?

The FMX system converts radio-frequency (RF) energy into heat through a process called ferromagnetic heating. FMX tools are electrically silent, meaning that no RF energy is emitted into the patient. FMX surgical tools cut, coagulate, and seal tissue with a pure thermal effect.

Is the FMX system cleared by the FDA?

Yes. The FMX Ferromagnetic Surgical System, which includes the FMX Generator, power modules, and surgical instruments, have all received 510(k) clearances from the FDA. Regulatory documents for the FMX system can be seen in our Download Library.

What training courses will this technology require prior to its use?

None. There is no new surgical approach or procedure training required. Typically the surgical staff undergoes a few minutes of product inservicing prior to initial use. Surgeons are usually comfortable using the technology after 2 or 3 procedures, and do not require additional in-procedure support.

What surgical instruments are available with the FMX system?

FMX ferromagnetic surgical technology is readily adaptable to a variety of surgical instruments.

 

  • FMwand hemostatic dissector: an intelligent thermal dissection device that precisely cuts and coagulates with a fraction of the tissue injury compared to monopolar electrosurgery, without passing any electrical current through the patient.
  • FMsealer Open Shears: a multifunctional thermal vessel sealing instrument that uses ferromagnetic technology to efficiently seal and divide tissue with minimal thermal injury to adjacent tissue in open procedures.
  • FMsealer Laparoscopic Shears: a precise vessel sealing istrument that uses ferromagnetic technology to reliably seal and divide tissue with minimal thermal injury to adjacent tissue in laparoscopic and open procedures.