New World Medical has announced an update to its launch plans for the STREAMLINE® Surgical System. STREAMLINE, a single-use device featuring the intuitive ClickPulse® Technology, is a first-line implant-free system designed to create precise goniotomies in the trabecular meshwork and deliver small amounts of ophthalmic viscosurgical device (OVD) into the canal of Schlemm in one unified step. The device offers surgeons a unique option that can be used as a stand-alone procedure or combined with cataract surgery. STREAMLINE received 510k clearance from the FDA on October 8, 2021, prompting New World Medical to initiate a limited soft launch plan that includes building experience amongst select US surgeons and commencing Phase 4 clinical studies.
“Since gaining FDA clearance in October, we have been working hard to prepare for full commercialization of STREAMLINE. We are pleased with the initial surgeon feedback, which has validated the need for a precise, implant-free, and minimally invasive surgical option. With full commercial availability scheduled for April 1, 2022, and Phase 4 studies in progress, STREAMLINE is positioned to become a compelling addition to our portfolio of innovative surgical products that benefit both patients and surgeons,” said Raymond Kong, Chief Commercial Officer of New World Medical.
Dr. Elizabeth Yeu of Virginia Eye Consultants explained, “We’ve had great success with the ever-growing list of devices for angle surgery. STREAMLINE is exciting because the ClickPulse technology allows us to combine the creation of micron-sized goniotomies in the trabecular meshwork with delivery of OVD into the canal of Schlemm in one unified step. This can be done as a standalone procedure or combined with routine cataract surgery. Rather than only treating one aspect of the conventional outflow pathway by implanting a stenting device during cataract surgery, we can use STREAMLINE to target the entire outflow system by creating precision goniotomies, dilating the canal of Schlemm, stretching the trabecular meshwork, and flushing the distal collector channels in one click of the button, without leaving an implant behind.”
“New World Medical does it again with the creation of an innovative, versatile, ergonomic single-use device for our angle surgery patients,” added Dr. Nathan Radcliffe, New York Eye Surgery Center. “STREAMLINE is an elegant new tool in my surgical toolbox that allows me to routinely and efficiently offer effective treatment to my patients.”
Read the full press release here: www.newworldmedical.com/new-world-medical-announces-launch-details-for-the-streamline-surgical-system/
Source: New World Medical