Creating precise goniotomies with novel surgical system

New World Medical 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 8 October, 2021, prompting New World Medical, a global medical device company focused on glaucoma interventions, to initiate a limited soft launch plan that includes building experience amongst select U.S. surgeons and commencing Phase 4 clinical studies.

Raymond Kong, chief commercial officer of New World Medical, noted in a statement that since gaining FDA clearance in October, the company has 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,” he said in a statement. “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.”

According to Dr Elizabeth Yeu of Virginia Eye Consultants, surgeons have 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,” Dr Yeu said in a statement. “This can be done as a standalone procedure or combined with routine cataract surgery.”

Dr Yeu also pointed out that instead of treating one aspect of the conventional outflow pathway by implanting a stenting device during cataract surgery, surgeons 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.

Moreover, Dr Nathan Radcliffe, New York Eye Surgery Centre, said the device allows him to “routinely and efficiently offer effective treatment to my patients.”