FlexDex intuitive laparoscopic accompaniments to begin sale in the US

Introduction of FlexDex intuitive technology has revolutionized the way minimal invasive surgeries are performed by lending the ease of movements and intuitive control than traditional laparoscopic instruments.

Using the ‘virtual center,’ the platform precisely translates the movement of surgeon’s wrist, hand, and arm outside the patient’s body into the corresponding movements of the instrument tip inside the patient body. Unlike any other instrument, it allows the surgeons to move the wrist in the direction of intended movement thereby greatly simplifying the execution of the surgical procedure.

Until now, FlexDex only provided the technology to a few hospitals as part of clinical trials. Now, FlexDex has entered into exclusive distribution agreement with Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures to distribute FlexDex’s Needle Driver instrument in the United States.

The agreement combines Olympus’ innovative 3D laparoscopic imaging technology and FlexDex’s wristed needle-driver to offer a low-cost, robust alternative for complicated high-cost robotic set-up.

Randy Clark, Group Vice President of the Surgical Division at Olympus said in a news release, “Combining Olympus’ expertise in minimally invasive surgery and 3D technology with FlexDex’s unique technology for handling surgical instruments -- without the complexity and cost of a computer-aided robotic system -- will be a game changer for physicians and patients. We are thrilled to add FlexDex to the Olympus portfolio, furthering our progress of improving patient satisfaction, decreasing costs and improving the quality of life for patients.”

“Hospitals are constantly under pressure to reduce cost and improve patient outcomes. Using a multi-million-dollar robotic system for procedures that have low margins, often associated with fixed reimbursement, can potentially further burden providers financially. FlexDex and Olympus are uniquely positioned to offer surgeons the precision and control they desire while maintaining the balance of cost, outcome and patient benefit,” added Dr. James Geiger, CEO at FlexDex.

Flashback: FlexDex, a revolutionary laparoscopic technology that moves like surgeon’s hand

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FDA approves Senhance Surgical Robotic System to facilitate minimally invasive surgery

FDA today approved Senhance Systems, by TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery.

Robotically-assisted surgical device (RASD) is a type of computer assisted surgical system, which helps surgeon to control, view and move the surgical devices through small ports of minimal invasive surgery in a variety of surgical procedures. It specifically has gynecological and colorectal applications.

The system enables the surgeon to sit in a console or a cockpit of some sort, which provides him or her with a 3D, high-definition view of the surgical field and allows for the control of the system’s 3 robotic arms. At the end of each of the 3 arms are mounted surgical instruments that are based on traditional laparoscopic instrument designs. This increases the surgeon’s comfort and reduces strain.

The system allows the surgeon to “feel” the stiffness of tissue during operation with its force feedback technology. It also features eye-tracking to allow for comparative movement of instruments to standard operations. It facilitates highly efficient operations with minimal additional docking time or change to technique.

 It allows for the visualization and endoscopic manipulation of human tissue, such as grasping, cutting, blunt and sharp dissections, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery," according to the FDA. 

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.” 

The clearance was based on results of a pilot study in which 150 patients underwent various gynecological operations with the Senhance System. The clinical outcomes were compared with outcomes of nearly 8000 surgeries in real world settings using another RASD.

In addition to gynecological surgeries, 45 colorectal sureries were also performed by Senhance system and compared to outcomes of other real-world surgeries.

Based on the study results, real world evidence and simulations, the FDA concluded that the  Senhance System is substantially equivalent to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

Here is a  video of Senhance Surgical Systems. 


Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.