CONTINUING THE
EVOLUTION OF
MINIMALLY INVASIVE SURGERY

CHALLENGE THE STATUS QUO ADDRESSING UNMET NEEDS IN SINGLE-SITE SURGERY

+ The Challenge

Reducing the number of incisions and minimizing abdominal wall trauma is the next logical step in the evolution of laparoscopic surgery as it has the potential to offer significant benefits over traditional laparoscopy.

+ Ease-of-use limitations

Today, general adoption of single-port methods has been hindered by ease-of-use limitations, associated with the inability to achieve adequate triangulation for optimal surgical manipulation, retraction, and exposure. This results in poor ergonomics, long learning curves, prolonged operative times, and potential for increased risk of visceral injury and surgeon morbidity.

+ Issues from large incisions

In an attempt to overcome these ease-of-use limitations, current day technology involves access incisions of 20-30 or even 50+mm in length, creating controversy regarding higher rates of incisional hernia, increased post-operative pain, and slower recovery.

Courtesy of UCSD Center for the Future of Surgery

INTRODUCING FMX314 THE FIRST AND ONLY 15MM SINGLE-PORT SURGERY SOLUTION

Delivering on the promise of single-port surgery

+ Small – 15mm access incision

FMX314 is the world’s first single-port platform that does not require a larger access incision than conventional laparoscopic surgery (15mm trocar compatible), addressing incisional hernia and post-operative pain concerns.

+ Simple – Improved triangulation

Achieving excellent triangulation and range of motion with hand orientation similar to conventional laparoscopy makes FMX314 easy to use, improving overall procedural efficiency and shortening learning curves.

+ Secure – Mimicking conventional laparoscopy

Closely mimicking conventional multi-port laparoscopy enables surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.


OUR TECHNOLOGICAL ADVANTAGE COMBINING MANUFACTURING AND DEVICE DEVELOPMENT EXPERTISE INTO A PRODUCT YOU CAN TRUST

A more productive and efficient advancement of innovative medical products.

+ The lean approach

Building on our established position as a stent industry leader with state-of-the-art laser cutting capabilities, we have the advantage of in-house control over the manufacturing of key components of the FMX314 platform.

Thanks to our network within the medical device industry, we are able to work with various professional service providers for the supply of other platform components and services. This allows us to outsource cost by leveraging their expertise and infrastructure.

+ Proprietary technology
  • Today, the FMX314 platform is protected by a growing IP portfolio of 27 US and international patent applications in various stages of approval including 11 patents granted.

THE FMX314 PROPOSITION OUR GROUNDBREAKING SURGICAL APPROACH IMPROVES HEALTH ECONOMICS IN TODAY’S COST CONSCIOUS HEALTHCARE ENVIRONMENT

+ Patients

Our 15mm single-port surgery solution offers patients the potential for improved health outcomes, including fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis.

+ Surgeons

Capturing the benefits of single-port surgery, our platform ultimately allows surgeons to provide better care, improving overall patient satisfaction. Also, the FMX314 offers surgeons the ability to comfortably perform single-port surgery in a manner closely mimicking traditional laparoscopy, enhancing ease-of-use and shortening learning curves.

+ Health system

Compatible for insertion through a single 15mm laparoscopic trocar, our platform potentially lowers hospital readmission rates to treat hernias and infections. Fewer incisions also accelerate recovery and return to the workplace, reducing the use of analgesics and improving overall procedural efficiency.

WHO WE ARE A RECOGNIZED GLOBAL LEADER IN MEDICAL DEVICE MANUFACTURING

Pushing innovation, staying ahead of the curve.

+ Improving quality of life by creating novel devices

As a global market leader in contract stent manufacturing, we have been a trusted partner in the medical device industry for over 15 years. Fortimedix Surgical is committed to continuing the evolution of minimally invasive surgery by driving technological innovation across surgical specialties to improve the quality of life of patients throughout the world.

Well known for state-of-the-art manufacturing capabilities and operational excellence, we offer unsurpassed service and dedication to customer satisfaction. We are now applying our knowledge and extensive expertise to challenge the status quo in minimally invasive surgery by creating novel devices that capture the claimed benefits of single-port surgery.

News & Events

510(k) clearance for FMX314 Surgical Platform
510(k) clearance signifies an important milestone in our quest to deliver on the promise of single-port surgery.
510(k) submission with FDA for FMX314 Surgical Platform
We are pleased to announce 510(k) submission with the FDA for our FMX314 single-port surgery platform, representing the next important milestone towards market introduction in the United States.
SAGES Emerging Technology Session 2016 (Boston, MA)
At SAGES 2016, Hans F. Fuchs, MD will present initial in vitro feasibility and cadaver study results with FMX314 modified for TaCR.

CONTACT US LEARN MORE ABOUT THE FMX314 PLATFORM

Fortimedix USA, Inc.
PO Box 9657
Rancho Santa Fe, CA 92067
United States
Fortimedix Surgical B.V.
Daelderweg 20
6361 HK Nuth
The Netherlands