Health Canada Approves Ventripoint’s Complete Heart Analysis System
Ventripoint has received a license from Health Canada for the new VMS-PLUS machine and the 4-chamber heart analysis system.
The VMS is already licensed in Canada for use for the right ventricle. The new product is an expansion of the VMS heart analysis product to include right atrium, left atrium and left ventricle chambers of the heart.
The expansion allows for measurement of volume and function for all four chambers of the heart using a 2D ultrasound.
Tryton Medical Gains FDA Approval for Tryton Side Branch Stent
Tryton Medical has received FDA approval for the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches.
The stent is intended for patients with large side branches — appropriate for a ≥2.5mm stent.
The device is available in multiple diameters and is compatible with any conventional drug eluting stent in the main vessel.
NxStage Medical Awarded CE Mark for its NxGen Hemodialysis System
Massachusetts–based NxStage Medical has received CE Mark approval for its next generation hemodialysis system.
The system has touchscreen user interface and an integrated blood pressure monitor designed for ease of use for patients performing home hemodialysis.
The system is currently under review for marketing clearance from the FDA.
FDA Grants Marketing Clearance to Nephros’ Endotoxin 10” Filter
New Jersey–based Nephros received clearance from the FDA to market its EndoPur endotoxin 10” filter.
The filter is designed to provide hemodialysis quality water to dialysis machines. The product fits into existing filter cartridge housings of reverse osmosis water systems that provide dialysis clinics with high volumes of ultrapure water.
The company will begin marketing the filter in the second quarter of 2017.
BTG Gains CE Mark for Drug-Eluting Bead
BTG has received Class III CE Mark certification for DC Bead LUMI, which is a radiopaque drug-eluting bead.
The bead can be loaded with doxorubicin or irinotecan for the local treatment of tumors in patients with hepatocellular carcinoma and malignant colorectal cancer metastasized to the liver.
The bead allows real-time confirmation of its location, enhancing the level of control in transarterial chemoembolisation procedures.
FDA Approves Spectral’s PMA Module for Treatment of Endotoxemic Septic Shock
Toronto–based Spectral received approval from the FDA for the third module of its rolling PMA submission from the FDA for Toraymyxin (PMX).
PMX is a therapeutic hemoperfusion device that removes endotoxin — which can cause sepsis — from the bloodstream.