Reverse Medical Corp.
California-based Reverse Medical landed key FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for treatment of intracranial bifurcation aneurysms.
The company plans to finalize its trial structure "very soon" and begin enrolling patients within the next few months, president & CEO Jeffrey Valko said in prepared remarks.
Reverse Medical secured European CE Mark approval for its UNO neurovascular embolization system, for obstructing blood flow in the blood vessels of the brain. The device also notched initial clinical use for intracranial specification.
Reverse Medical this month won 510(k) clearance from the FDA for its MVP-5 micro vascular plug system.
The MVP-5 is indicated for the treatment of peripheral vessel embolization. The vascular plug is designed to obstruct or reduce the rate of blood flow in the peripheral vasculature, particularly in vessels measuring between 3.0 and 5.0 mm, according to a press release.
Reverse Medical said it won CE Mark approval in the European Union for its Barrel vascular reconstruction device.
The Barrel device is designed to be used with occlusive devices when treating intracranial aneurysms, according to a press release.
Reverse Medical Corp. said it won CE Mark approval in the European Union and 510(k) clearance from the FDA for its ReVerse neurovascular microcatheter device.
The regulatory nods are for use in the neurological, peripheral and coronary vasculature for the infusion of diagnostic and therapeutic agents, according to a press release.
Irvine, Calif., medical device maker Reverse Medical Corp. touted FDA clearance for its flagship product, the MVP micro vascular plug for peripheral artery embolization.
The plug helps decrease blood flow in the peripheral vasculature and is "completely re-sheathable" for use in procedures where a patient needs only temporary blood flow reduction.
Reverse Medical won European approval for its MVP Micro Vascular Plug system for peripheral artery embolization and the company signed a deal with Century Medical for distribution of its products in Japan.
Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.
Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.