Robotic Gamma Probe Approved For First Time In Europe
Date posted:
News
Lifescience Industry magazine reports that Lightpoint Medical, the medical device company, has announced on 21 January 2021 that it has received CE Mark approval for SENSEI®, its robotic gamma probe. The company specialises in developing miniaturised surgical tools for advanced intra-operative cancer detection.
SENSEI® is the first instrument of its kind to be commercially available to European hospital systems. It is designed for precise intra-operative detection of sentinel lymph nodes, and also cancer metastasis through the lymphatic system. It can target many of the major types of cancer, such as prostate, lung, stomach, and gynaecological.
The SENSEI® probe was designed in close collaboration with top surgeons and nuclear medicine physicians. It provides a clear audible and graphic display, and can be integrated with an external display on surgical robotic platforms. The probe is single use and disposable, to eliminate the risk of cross-contamination.
The miniaturised probe (40mm long) is extremely manoeuvrable, and is able to quickly locate radioactive hotspots. The radio-guided system is attached by a 3-metre lightweight cable of 12mm standard diameter. It is designed to be minimally invasive, whilst maximising dexterity when used with an articulating grasper.
The new device has been widely endorsed by leading cancer surgeons worldwide. Robotic surgeon, Dr Jim Adshead, at the Lister Hospital, East and North Herts NHS Trust, comments:
“I am very excited about regulatory approval for SENSEI® and now eager to start using it in surgery. I have been closely involved in the development of the technology since early usability testing and I’m extremely hopeful for its potential in advancing the treatment of prostate cancer.”
Professor Declan Murphy, robotic surgeon at Peter MacCallum Cancer Centre, Melbourne, Australia, has also endorsed the device:
“I am delighted that SENSEI® has received CE Mark. Our team is very keen to start using the technology in prostate cancer surgery using the da Vinci robot. As a leader in research in robot-assisted prostate cancer surgery and molecular imaging using PSMA, we are extremely excited about the prospects for SENSEI® to improve outcomes for our patients.”
Lightpoint Medical is a UK company, but thanks to a partnership with the UK trade association ABHI, they have already successfully registered their device with the FDA, and it is currently authorised for sale in the US, which is the world’s biggest medical device market. The ABHI US Accelerator programme works to facilitate entry into market for UK companies.
Paul Benton, the ABHI’s International MD, commented:
“We are thrilled to hear of Lightpoint Medical’s latest achievement in obtaining CE for their ground-breaking miniaturised device. [] With cancer rates increasing globally, the device offers a valuable tool allowing surgeons to detect cancer more accurately and is a fantastic example of UK innovation.”
SENSEI® locates cancer-targeted drugs for cancer metastasis detection, such as Prostate Specific Membrane Antigen in prostate cancer surgery. It also locates radioligands such as 99mTc-nanocolloid for sentinel lymph node detection. The CE Mark approval for the wider distribution of the device is for sentinel lymph node detection.
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