A simple, novel solution to identify and protect ureter during surgery

AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held, single use device that precisely identifies ureter during surgery; thus, eliminating the need for ureteral stenting.

It is specifically useful in all gynecological, colorectal and oncosurgeries. Gynecological surgery accounts for 50% of all iatrogenic ureteric injuries.

It is estimated that around 3 million surgeries performed in US annually, require an identification of ureter. The rate of ureteric injuries is around 2% with disastrous consequences and the total healthcare burden of this complication is about $3.2B every year.

It is also estimated that about 30% surgical time is spent on identifying the ureter.

The surgeon can simply place the tip of the device in the vicinity of the ureter and with a push of a button, the ureter goes into contraction and the full length of ureter towards kidney and bladder can be identified.

There is no other smooth muscle structure in that anatomical region, so the device specifically identifies ureter only.

The device is single use, battery operated and avoids additional procedures like cystoscopy on the operation table.

Allotrope aims to initially market the device for two high volume procedures, Hyterectomy (750,000 in US) and colon resection (300,000 cases). The current alpha prototype is a hand held, stand alone device that can be used in both open and minimal invasive surgeries. The company plans to enter the Robotic market in future by designing device for their platforms.  

Currently, StemSite is at pre-FDA state, but plans to get FDA clearance through the 510(k) pathway, and entering the marketplace by first quarter of 2019.

Allotrope has recently won second place in MedTech Innovator’s 2017 competition, among 600 startups.

Here is a video by Allotrope showing the functioning of the device. 

Hologic, Inc launched MyoSure MANUAL, for in-office intrauterine tissue removal

Hologic, Inc today expanded its Myosure portfolio by adding the MyoSure MANUAL device which enables physicians to more easily resect and remove intrauterine polyps and fibroids in office settings when used along with the MyoSure hysteroscope.

The device comes with an ergonomically designed blade that can be rotated through 360 degrees, enabling wide range of smooth motion. The system does not require cauterization and have a transparent tissue trap that allows the physician to see the specimen and can holds up to 4gms of tissue.

The tissue trap can be detached, and the specimen can be sent for direct histopathological examination.

In addition, the system also comes with a built-in vacuum, eliminating the need of external suction and works with a one-liter saline bag. 

The complete MyoSure system is a minimally invasive hysteroscopic treatment for women with Abnormal Uterine Bleeding (AUB) due to polyps or fibroids and requires no cauterization, which preserves uterine form and function.

Edward Evantash, M.D., Medical Director and Vice President of Medical Affairs, Hologic said in a press release, “We recognize the increased demand for in-office procedures, and seek to develop innovative solutions to provide flexibility and convenience for both physicians and patients. The MyoSure MANUAL device was designed for in-office tissue removal procedures, requiring minimal setup and no vacuum or fluid management system, while offering direct visualization when used with the MyoSure hysteroscope."

 “The MyoSure MANUAL device is an exciting addition to Hologic's growing portfolio of gynecologic solutions, developed with the patient and physician in mind. This addition to the MyoSure product suite signals our ongoing commitment to providing effective surgical solutions that can be performed in office to address our customers' needs and improve the overall patient experience," added Sean Daugherty, President of GYN Surgical Solutions at Hologic.

Contraindications for the use of MyoSure MANUAL Tissue Removal Device includes  pregnancy or suspected pregnancy, has clinical evidence of an active pelvic infection or history of a recent pelvic infection, or has cervical malignancies or previously diagnosed uterine cancer.

Other devices in Myosure Portfolio include MyoSure^®, MyoSure^® REACH, MyoSure^® XL, and MyoSure^®LITE devices.

Complete MyoSure MANUAL device Instructions for use

Press Release

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Ethicon launches ProxiSure Suturing Device, improving precision in Minimal Invasive Surgery

Ethicon, part of the Johnson & Johnson Medical Devices Companies, announced today the U.S. launch of the ProxiSure™ Suturing Device, an advanced laparoscopic suturing device armed with Ethicon endomechanical, suture and curved needle technologies.

ProxiSure Suturing Device boasts wrist-like maneuverability and curved needle suitable for operating in tight spaces giving surgeons confidence similar to open surgeries. The suturing precision and ease is achieved because surgeons can reach the desired angle, control bites and and secure knots, with having maximum control of the needle during suturing and knot tying all along.

Dr. Niels-Derrek Schmitz, Franchise Medical Director for Ethicon said, "With the patient's health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will now be able to have the same confidence in laparoscopic suturing that they have always had with traditional procedures using Ethicon products."

"Versatility is the key," said Dr. Schmitz. "ProxiSure enables surgeons to do a wide range of tasks in the OR while maintaining an immensely user-friendly configuration." 

ProxiSure Suturing Device is suitable for use in gynecological procedures, bariatric, general and colorectal surgeries, enabling the surgeon to suture a variety of tissue layers, including flat surfaces.

                                    PROXISURE™ Suturing Device In-Service

Media Courtesy: Ethicon.

Medtronic launches Signia(TM) Stapling System for innovative Minimally Invasive Surgery

Medtronics.com 

  

Medtronic today announced the launch of its Signia(TM) Stapling System, which has Adaptive Firing(TM) technology to detect the tissue strength and type of tissue worked at allowing for consistent staple lines. This is in line with the company’s commitment to develop and enhance Minimal Invasive Surgery capabilities and technology. 

Medtronics.com

Human tissues have variable thickness and consistency throughout body, so the Signia stapling system can measure the force required for a specific tissue and adjust the speed of firing staples.

The device also includes one single handheld firing gun to allow the operator’s more choice and ease of use keeping the other hand free.

"The Signia system is a first-of-its-kind stapling system and represents our commitment to pioneering intelligence-based minimally invasive surgical solutions," said Chris Barry, senior vice president and president of the Surgical Innovations business, which is part of the Minimally Invasive Therapies Group at Medtronic. "Ultimately, healthcare should help patients get better, faster with less pain; MIS delivers on that commitment."

Dana Portenier, M.D., FACS, co-program director, Duke Minimally Invasive and Bariatric Fellowship division chief, Duke Metabolic and Weight Loss Surgery Duke Regional Hospital, chairman of surgery said "In my experience to date, I believe the articulation, rotation and firing of the Signia system provides an important new option in the performance of minimally invasive surgical procedures. Its ability to provide the surgeon with helpful data and real-time response has the potential to contribute to more informed surgical decision-making."

The initially launch is limited to the United States, Western Europe, and Japan. It is expected to roll out to additional global locations during the company's fiscal year 2018.

                                             Medtronic Signia Stapling System