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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Olympus newsrelease

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New approach to myomectomy: Transvaginal natural orifice transluminal endoscopic surgery

Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure where ‘scarless’ abdominal surgeries are performed through an endoscope inserted through a natural orifice (mouth, anus, vagina, and urethra) and is considered as a less invasive approach to laparoscopic surgeries.

NOTES is considered a logical next step in the evolution of minimal invasive surgery, and the first NOTES procedure in humans is often considered to be a transgastric appendectomy performed in India in 2006 which was presented but not reported in manuscript form.

vNOTES is a natural orifice surgery performed through vaginal route. A look into history reveals that gynecologists have been performing colpotomies since years, adding their valuable experience towards NOTES surgeries and subsequent closure.

A recently published paper in January issue of Fertility and Sterility have demonstrated a new technique of performing myomectomy by this route and reports the technique and results of a small study involving 8 patients. Eight patients were treated transvaginally for intramural, subserosal, and pedunculated myomas.

The study was conducted at Gynecology department of a non-university teaching hospital in Belgium.

In case of the anterior myoma, anterior colpotomy was used to gain access to the peritoneal cavity, if the myoma was located posteriorly, a 2.5-cm posterior colpotomy was made under general anesthesia. The pouch of Douglas was opened and a vNOTES port was inserted transvaginally.

A pneumoperitoneum was created and the myoma was identified. With the use of conventional endoscopic instruments and a standard endoscope, all inserted through the vNOTES port, the uterine serosa was incised over the myoma and the myoma was resected. After achieving hemostasis, the uterine scar was sutured in two layers with the use of a standard absorbable suture or an autolocking suture.

 An adhesion-preventing barrier was applied over the uterine scar. The myoma was removed through the colpotomy in an endobag. The vNOTES port was removed and the colpotomy was sutured with the use of an absorbable suture.

The patients’ data collected included demographics, number of previous abdominal surgeries, myoma size, myoma weight, operating time, length of hospital stay, visual analog scale pain score, and serum hemoglobin drop.

All fibroids were successfully removed without any intraoperative or postoperative complications via vNOTES without converting to open or standard laparoscopic access. Patients were discharged within 24 hours, 2 of them went home in 12 hours.

In a developed setting, the surgical time can be reduced with the use of an autolocking suture and a commercially available vNOTES port, while in low resource setting it can be replaced by standard absorbable suture and a self-constructed gloveport, as clearly seen in the following video.

The authors concluded that vNOTES provides a new less invasive approach for the resection of myoma types 3–7 that are conventionally resected via laparotomy, laparoscopy, or transabdominal robotic surgery.

This was the first successful IDEAL (idea, development, exploration, assessment, long-term study) stage 1 study which confirmed the feasibility of vNOTES myomectomy. This novel approach not only provides a better cosmetic result than conventional laparoscopy but also improves patient comfort.

Larger studies are warranted in future. 

A new approach to ovarian cystectomy: Transvaginal natural orifice transluminal endoscopic surgery

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Here is the video of stepwise explanation of the technique.

Fast and reliable Ferromagnetic vessel sealer launched for all Laparoscopic surgeries

Domain surgical recently announced the launch of FMsealer Laparoscopic Shears, the latest addition to its FMX Ferromagnetic Surgical System. The FMsealer Laparoscopic Shears seal the vessels in half the time as compared to bipolar and ultrasonic shears.

The sealers work on the principles of ferromagnetic surgical energy offering faster surgical transection and minimal thermal impact to surrounding tissue. It has a patented active cooling system that ensures localization of heat in the jaws and provides a rapid cool down following deactivation. It also does not transmit electric current to the patient, making it safe to operate near metal staples, clips, and instruments.

Bipolar, ultrasonic and Ferromagnetic energies 

The surgeon can change between ‘seal’, ‘seal and divide’ and ‘high-power seal and divide’ modes easily based on different tissue interactions. It efficiently seals vessels up to and including 7 mm in diameter, including lymphatics in both open and laparoscopic procedures.

The FMsealer was found effective in the clinical trial and fared better in terms of thermal impact, sealing larger vessels and patient safety as compared to bipolar and ultrasonic sealers. The study was published in the Journal of Surgical Laparoscopy, Endoscopy & Percutaneous Techniques in 2017.

OmniGuide, Inc.’s CEO John Buhler said, “The FMsealer provides surgeons with an optimal combination of reliability, efficiency, customization, and safety in a variety of laparoscopic procedures, without passing potentially dangerous electrical current through the patient.”

Here is the video of FMsealer during a Laparoscopic Toupet Fundoplication procedure.

OmniGuide press release

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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.

World’s first system to eliminate surgical smoke and improve visibility in laparoscopic or robot-assisted procedures gains FDA approval.

courtesy:Cardiff University

Alesi Surgical Limited, leading innovator of Minimally Invasive Technology gains FDA approval for its Ultravision system. It is world’s first technology that not only clears surgical smoke, but eliminates it to improve visibility of the surgical field. Particulate matter and smoke is generated by cutting instruments during the modern laparoscopic abdominal surgeries obscuring the surgical field.

Dr Dominic Griffiths, Managing Director of Alesi Surgical said “We are thrilled to have gained FDA approval for our Ultravision system that will now allow us to enter the US market. Commercially the US represents approximately fifty per cent of the global medical device market and so it is difficult to overstate the importance of this for the company.”

When a surgeon uses Ultravision, the surgery is quick, requires few lens cleaning along with significantly less use of carbon dioxide. Keyhole surgeries are known to use several hundred liters of carbon dioxide to get a clear vision of the surgical field, which prolongs the recovery time and causes post-surgical pain.  

The Ultravision system works by producing negatively charged gas ions in the abdominal cavity, which move towards the “positive” patient tissue. As the ions move, they collide with water vapour and particulate matter and draw them away from the surgical site. Particles land, and the electrical charge flows back to the generator.

After 1 minute of continuous use, smoke evacuation removes 30.2% of particles (by number) In the same time period Ultravision™ precipitated 99.9% of particles, independent of particle size, from 7nm to 10µm (p<0.05).

It is estimated that over seven million abdominal keyhole procedures are performed annually, worldwide.

                             The video demonstrates the mode of action of Ultravision.

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

FlexDex.com 

FlexDex, a new minimally invasive surgical tool system developed by University of Michigan startup FlexDex Surgical has been in use for the first time in a series of operations. FlexDex has already begun shipping its product throughout the U.S. This new $500 surgical instrument is vying to take the place of a $2 million robot for certain minimally invasive procedures.

The FlexDex is very intuitive and ergonomic to use, provides greater precision and functionality. The new technology gives surgeons higher degree of dexterity and intuitive control than traditional laparoscopic instruments.

FlexDex is an all-mechanical platform that mounts to the surgeon's arms and precisely translates the surgeon’s hand, wrist, and arm movements that are performed outside the body into corresponding precise movements inside the patient’s body. The FlexDex concept is the result of two major innovations that has revolutionized the physical configuration of hand-held, mechanical tools.

1. A mechanism around the surgeon’s wrist that geometrically projects a ‘virtual center’ of rotation at the same point as the surgeon's wrist.
2. This ‘virtual center’ mechanism is placed between the tool handle and a tool frame, which is now attached to the surgeon’s forearm via an arm-brace.

Inventor of FlexDex

The movements of the surgeon’s hands are directly transmitted to the tool shaft and end-effector. The surgeon’s wrist is allowed to rotate freely and naturally while the working tip inside the body flexes in the same direction as the handle and it can be rotated 360 degree with the help of the handle.

There are no buttons or lever to press but only a trigger that always rests in the palm that is used to activate the instrument at the tip.

Geiger demonstrated: "If I move my hand up, the device tip goes up. Wherever I move my hand, the tip of this instrument follows." No other instrument currently on the market operates like this.

To stitch internally, for example, surgeons can opt for old-fashioned straight-stick instruments that make complex tasks like suturing and knot-tying ergonomically challenging and extremely difficult to learn, Geiger said. Or they can use the high-tech daVinci Surgical System, a robot-assisted approach that's not available at all hospitals due to its cost. It takes considerable training to learn how to use a robot-assisted system.

 This startup is the brainchild of Shorya Awtar, a University of Michigan (U-M) engineering professor who co-founded FlexDex with his U-M colleague and surgery professor, James Geiger, and entrepreneur Greg Bowles.

"FlexDex provides the functionality of robots at the cost of traditional hand-held laparoscopic instruments. We've disrupted the paradigm where surgeons and hospitals had to choose between high cost/high function and low cost/low function," said Awtar "It's kind of like the transition from mainframe computers to smartphones. You hardly need a manual to use it. It's just intuitive." 

To contact FlexDex surgical call 810-775-3352   Mail:info@flexdexsurgical.com

                                              FlexDex | A Revolutionary Surgical Tool

                                              FlexDex | A Revolutionary Surgical Tool