Image: Precision-GI Endoscopic Biopsy Device (photo courtesy of Limaca Medical)
Endoscopic biopsy is performed by a gastroenterologist who accesses the targeted gastrointestinal (GI) tumor using an ultrasound viewing endoscope. Suspicious locations of gastrointestinal tumors include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, and in organs related to the gastrointestinal tract such as the pancreas and liver. Today’s endoscopic biopsy devices have limitations in consistently obtaining sufficient quality tissue, which can lead to tissue sample fragmentation, inadequate tissue quantity, and blood contamination. Now, a new endoscopic ultrasound biopsy device with a unique motorized and automated rotating cutting needle is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening gastrointestinal cancers more quickly and efficiently. less traumatic than current products.
The Precision-GI device from Limaca Medical (Yokneam, Israel) is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract. It is deployed and operated through an instrument channel in the endoscope to biopsy the tumor. While all existing endoscopic ultrasound fine-needle biopsy (EUS-FNB) devices require manual operation, Precision GI features a unique motorized and automated rotary cutting needle for successful tissue acquisition. The automated design allows for more effective and efficient diagnosis of gastrointestinal cancers since it is designed to produce significantly higher quality and quantity of diagnostically relevant biopsy tissue.
Initial cases from Limaca’s ongoing Comparative Clinical Feasibility Study demonstrate that Precision GI has obtained contiguous intact central tissue specimens that are fully adequate for the definitive diagnosis of pancreatic lesions. Clean, uncontaminated tissue samples provided a high percentage of tumor content, with less blood and extraneous fluids. Limaca’s Precision-GI Endoscopic Ultrasound Biopsy product has received Breakthrough Device Designation from the United States Food and Drug Administration (FDA). As part of the program, the FDA will provide Limaca with the opportunity to provide feedback during the pre-marketing phase and priority review of the device submission.
“We are delighted with the FDA’s decision to grant Precision-GI Breakthrough Device Designation,” said Carl Rickenbaugh, CEO of Limaca. “At Limaca, our vision is to ensure that endoscopic biopsies always result in a definitive diagnosis to enable optimal and timely treatment of gastrointestinal cancer. We are dedicated to the mission of providing a much better endoscopic biopsy experience for the endoscopist and the patient, with the goal of achieving faster, more efficient biopsy throughput with highly consistent results. With the breakthrough device designation, we look forward to accelerating our progress toward our goal of obtaining 510 clearance. (k) of the FDA to bring Precision-GI to patients in the United States in the near future.”
“Precision-GI is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy results for the evaluation of gastrointestinal malignancies. Endoscopic biopsy is a highly specialized and highly skilled procedure. innovation from Precision-GI that can provide automation and standardization of results with less operator-to-operator variation,” said Seth A. Gross, MD, Clinical Lead, Division of Gastroenterology and Hepatology , NYU Langone Health. “Our field is moving towards individualized patient-centered cancer therapy, known as precision medicine, which requires consistent quality and quantity of endoscopic biopsy tissue, allowing for optimal profile matching. tumor genetics to personalize a patient’s treatment plan.”