Limaca Medical Completes 24 EUS Pancreatic and Liver Biopsy Cases
Limaca Medical announced the successful completion of 24 cases using its Precision-GI™ endoscopic ultrasound guided motorized fine needle biopsy (EUS-mFNB) device on May 15, 2024. The device, used in both pancreatic and liver biopsies, showed significant tissue acquisition capabilities. Six cases involved the pancreas and eighteen the liver. Two-thirds of the cases were completed with a single needle pass, achieving top-grade biopsy samples in 21 out of 24 cases. The Precision-GI™ device, designed to obtain biopsies for definitive diagnoses of gastrointestinal cancers, has received FDA Clearance and Breakthrough Device Designation. Dr. Carlos Robles-Medranda, who led the study, praised the device for its efficiency and quality of biopsy tissue obtained.
- Precision-GI™ device received FDA Clearance and Breakthrough Device Designation.
- Significant tissue acquisition with the Precision-GI™ device, achieving top-grade biopsy samples in 21 out of 24 cases.
- Two-thirds of the biopsies completed with a single needle pass, reducing procedural trauma.
- Precision-GI™ demonstrated efficiency in obtaining contiguous intact core tissue samples.
- The study indicates the device can deliver higher quality and quantity of diagnostically relevant biopsy tissue.
- Positive feedback from Dr. Carlos Robles-Medranda on the ease of use and quality of tissue obtained.
- data sample of 24 cases may not fully represent the device's overall performance.
- Potential for device performance variability in a broader clinical setting yet to be fully evaluated.
- High dependency on operator skill, as evidenced by specific cases led by a highly experienced doctor.
Limaca's Precision-GI™ endoscopic ultrasound guided motorized fine needle biopsy (EUS-mFNB) device delivers substantial tissue acquisition.
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Six cases were in pancreas, eighteen were in liver. Two-thirds of the cases were completed in a single pass in and out of the endoscope with a median average of three total motorized actuations of the coring needle to achieve overall excellent biopsy results. In 21 of 24 cases, the biopsy samples achieved the top grade of Exceeded Clinical Expectations.
Precision-GI obtains tumor tissue within or adjacent to the gastrointestinal tract, accessing targeted tumors via the working channel of ultrasound visualization endoscopes.
Unlike traditional manually operated endoscopic ultrasound fine needle biopsy (EUS-FNB) devices requiring repetitive stabbing with a manual needle, Precision-GI features a unique motorized rotational cutting needle for maximal tissue acquisition. Other endoscopic biopsy devices have limitations relative to consistently obtaining quality tissue, sample tissue fragmentation, and blood contamination.
Precision-GI is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more efficiently and less traumatically than current products. The automated design is intended to yield significantly greater quality and quantity of diagnostically relevant biopsy tissue. With twenty-four cases completed by Dr. Robles-Medranda and colleagues, the ongoing study demonstrates that Precision-GI is quickly and efficiently obtaining contiguous intact core tissue samples for definitive diagnosis of target tissues.
Dr. Carlos Robles-Medranda commented, during a recent medical conference's live televised Precision-GI case, on his experience: "I believe there are several advantages. You can see the needle very well. I just pushed the button. And now we see the result of the biopsy after just one pass. This is the core you see. It is not bloody. No red stuff. It's very clear, the quality of the biopsy tissue is impressive. I've used core needles for many years, and they're still bloody, for example with the liver. When you have hard tissue, it is very difficult when you are pushing manually. The lesion moves sometimes. This is one of the things that I believe could be an advantage. This needle, in spite of being a 20 gauge needle, is really flexible. This will be very revolutionary for quality of tissue overall, and the results we need to evaluate comparing to standard core needles."
About Limaca Medical
Limaca Medical, Ltd, is a privately held company based in
Contact:
Assaf Klein, CEO
Assaf@limaca-medical.com
SOURCE Limaca Medical
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