Boston Scientific Gets CDSCO Panel Nod for Pivotal Clinical Investigation of MANTIS Clip
New Delhi: Boston Scientific has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the pivotal clinical investigation of the MANTIS Clip with the condition that the firm should include one more clinical study site from the government institutes for the study.
This came after the firm presented the proposal for a pivotal clinical investigation of the MANTIS Clip in the country on the Indian population before the committee.
MANTIS Clip is purpose-built for closing large defects in the GI tract. With proprietary TruGrip anchor prongs, MANTIS is designed to deliver tissue span and apposition capabilities, enabling a novel approach to close defects less than 3 centimeters.
An endoclip is a metallic mechanical device used in endoscopy in order to close two mucosal surfaces without the need for surgery and suturing.Endoscopic clips will usually fall off in 2 to 6 weeks, although it sometimes can take much longer (i.e. up to a year). These clips are very small and will pass naturally during a bowel movement.
At the recent SEC meeting for Gastroenterology and Hepatology held on 14th June 2023, the expert panel reviewed the proposal presented by Boston Scientific for the pivotal clinical investigation of the MANTIS Clip.
After detailed deliberation, the committee recommended the grant of permission for the conduct of the pivotal clinical investigation of the product on the Indian population with the condition that the firm should include one more clinical study site from the government institute for the study.
Accordingly, the expert panel stated that the firm should submit an amended clinical investigation protocol for further review by the committee
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