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. 

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.

Regular Aspirin use reduces the risk of cancer death: News from AACR annual meeting.

courtesy:corbis 

Long term, regular use of aspirin cut down the death rate in several types of cancers, according to an observational study presented at the American Association for Cancer Research(AACR) 2017 Annual Meeting, April 1-5.

The overall mortality rate was 7% lower in women and 11% lower for men in aspirin users and cancer mortality rate was 7% lower for women and 15% lower for men.

The researchers did a follow-up of 130,183 health professionals consisting of 86,206 women who were participants in the Nurses’ Health Study between 1980 and 2012, and 43,977 men who were recruited in the Health Professionals Follow-Up Study from 1986 to 2012.

The cohort was followed up for 32 years with aspirin use assessed at baseline and thereafter every two years.

During the follow up period 25% women and 33% men died, of which 37.5% women and 31% men’s death were because of cancer.

The strongest reduction in deaths were observed in colorectal cancer, with the relative risk lowered by 31% for women and 30% for men. Men who took aspirin regularly also had 23% lower relative risk of mortality due to prostate cancer, while women had 11% lower risk of dying from breast cancer.

Aspirin was beneficial in standard dose of .5 to 7 tablets per week, with a minimum of 6 years for reaping the benefits of lower mortality in cancer.

The USPSTF recommends “Initiating low-dose aspirin use for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years.”

The study’s lead author, Yin Cao said “These findings suggest that aspirin’s established benefits in cardiovascular disease and colorectal cancer reduction may extend to other common causes of death, including several major cancers. She said that while the study supports the long-term use of aspirin, patients and physicians should consider all potential benefits and risks, as well as individual health factors, when considering whether a patient should routinely take aspirin.”

“We need to conduct additional work to balance these benefits against the harms of use, such as gastrointestinal tract bleeding and hemorrhagic stroke,” she said.

The study’s observational design was a limiting factor making it less definitive than results of randomized trial.

Wonderdrug ' Metformin', the next breakthrough in anti-aging.

Common Diabetes drug Metformin could be next breakthrough in Anti-aging.