AqueSys has a gel stent, Xen, which bypasses the trabecular meshwork to create its own outflow into the subconjunctival space. The 6-mm stent is about the diameter of a human hair and uses flow mechanics to prevent hypotony.
The internal bleb becomes a low-lying drainage area with fewer post-op complications and management issues than ab externo dissected blebs, said Ron Bache, president and CEO. International data show a mean IOP reduction of 40% with a simultaneous 73% reduction in medication use. The device is used more often as a solo procedure (54%) in Europe versus a combination cataract procedure (46%). The company hopes for U.S. marketing approval by late 2016.
“Minimally invasive is important in devices, but it is not enough,” Bache said. “You need proven efficacy and the ability to intervene early. We give you all three in bypassing existing obstructions and introducing a new outflow pathway.”
InnFocus showed a dramatic drop IOP from 23 mm Hg pre-insertion to 10.9 mm Hg at 3 years in multinational studies. Patients went from a mean of 2.8 medications to 0.5 medications over the same 3 years and 73% of patients were medication free. The company is enrolling for a 439-patient IDE study comparing its MicroShunt against trabeculectomy. Reimbursement codes are already in place.
“Our MicroShunt can be used anywhere along the clinical pathway in glaucoma,” said Russ Trenary, president and CEO. “We want physicians to think low IOP and this is a way for them to get there.”
New World Medical