Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device.
The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said.
“I look forward to offering CorPath GRX to my patients during PCI, especially in complex procedures where precision and procedural control are extremely valuable. We are pleased to be one of the first Asia-Pacific countries to adopt this new and innovative technology,” Dr. Takafumi Ueno of Japan’s Kurume University Hospita said in a press release.
Last February, Corindus inked a Japanese distribution deal for its CorPath GRX device that included a $2 million advance and provision for 12 of the robot-assisted surgery platforms.
“There is strong demand for robotic-assisted intervention from key opinion leaders and the broad clinical community in Japan. PMDA approval of CorPath GRX in Japan represents a significant step in our ongoing effort to bring cutting-edge vascular robotics to global markets. We believe robotics has the potential to enhance patient care in Japan by offering the benefits of robotic precision and advanced tools for physicians to perform these life-saving procedures,” prez & CEO Mark Toland said in a prepared statement.
The Waltham, Mass.-based company said it is pursuing reimbursement coverage for robotic percutaneous coronary intervention procedures in the region and has planned for a post-market study of the device.
Last month, Corindus saw shares fall after the robotic-surgery platform maker missed sales expectations on Wall Street with its first quarter 2018 earnings results.
The post Corindus wins Japanese PMDA clearance for CorPath GRX platform appeared first on MassDevice.
from MassDevice https://ift.tt/2JuwoXg
Cap comentari:
Publica un comentari a l'entrada