INTENDED USE: STREAMLINE® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of ophthalmic viscoelastic fluid. The inner cutting cannula of the STREAMLINE® Surgical System is intended to create incisions in the trabecular meshwork tissue.
PATIENT POPULATION: ADULT
PROJECT NAME: CPI
DEVELOPMENT TEAM:
- STREAMLINE: John Koontz, Harold Miller (Project Lead), Eric Porteous (Tech Lead), Joey Tran (Independent Reviewer), Vijay Bilan, Nico Slabber, Lee Yick, Elyse Tighe, Nathan Collins, Carlos Mendoza, Nghia Ho, Andre Badea
- STREAMLINE 1.5: Chris Kee (Project Lead), Lee Yick (Tech Lead), Helena Gan, Joey Tran (Independent Reviewer)
PRODUCT SUPPORT:
EXECUTIVE TEAM: Bilal Khan, Khalid Mansour, Rafael Chan, Raymond Kong, John Koontz, Cristina Avalos, Brandon Blanche, Oswaldo Pompa
COMMERCIAL TEAM: Rafael Chan, Raymond Kong, Annamarie Piccioni, Brendon Keiser, Malika Singh, Jackie Martinez, Simon Oram, Jim Guarnera, Ray Nix, Clay Johnson, Michael Knutz, Yasir Iqbal, Toya Ashley
QUALITY AND REGULATORY TEAM: Cristina Avalos, Daniel Martell, Andre Badea, Billy Lu, Praveen Panasa, Ramon Venegas, Vinay Biligiri, Lorena Diaz, Erick Nunez, Marlon Vera Ornelas, Victor Arellano, Mukesh Sabarad, Yogi Shah, Komal Singh, Nancy Rivera
CLINICAL AFFAIRS TEAM: Theresa Landry, Heather Reynolds, Kendra Wright, Dr Malik Kahook (CMA)
LEGAL TEAM: David Klann
PRODUCT DEVELOPMENT DURATION: 30 MONTHS (11/2018 – 5/2021)
REGULATORY CLEARANCE RECEIVED: FDA 510(k) K211680 OCTOBER 8, 2021
DID YOU KNOW:
- The project name “CPI” was an acronym for “Clear Path Injector” but when project “Cortez” was nearing commercialization, it took the name “Ahmed ClearPath” so the project name just remained “CPI” until commercialization where it took on the name “Streamline Surgical System”
- Early prototypes had a green polymer tip. Surgeon feedback led to the tip being tinted blue to avoid color blind user issues.
- One version of prototype had the injection assembly moving forward but this was rejected due to safety concern for damage to the back wall of Schlemm’s Canal
- Early prototypes started with a glass distal tip. They were very functional but too fragile. Stainless steel was selected once capable suppliers were identified.
- Project development happened during the COVID-19 pandemic. The organization managed this challenge in every aspect of the project to try to keep it on schedule for a soft launch scheduled in the second half of 2021. Truly an organizational effort!
SURGEON / PATIENT TESTIMONIALS:
PROTOTYPE PHOTOS
PRODUCTION DEVICE EXPLODED VIEW
