EU APPROVAL GRANTED TO MEDTRONIC’S VALIANT NAVION THORACIC STENT GRAFT.
The Valiant Navion thoracic stent graft produced by Medtronic which was developed to treat lesions has been cleared in the EU in addition to the FDA approval it received in October 2018.
The device will be beneficial to patients which have narrow iliac arteries who previously may have needed additional procedures just to get overall treatment started.
The basis for the Valiant Navion is the Valiant Captivia thoracic stent graft system. Enhanced routing through a patient's anatomy has been achieved due to the new innovation having a more narrow profile. Furthermore, it is available in two variations enabling a larger number of patients to be treated by healthcare professionals.
Professor Fabio Verzini, M.D., Ph.D., associate professor of Vascular Surgery, University of Turin said:
“In clinical practice we often see patients with a wide range of thoracic aortic anatomies. For example, TEVAR in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure. “The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients and those who were previously considered ineligible for TEVAR with a percutaneous approach.”
VANTAGE ORIAN 1.5 TESLA MRI BY CANON CLEARED BY FDA
FDA clearance has been granted to Canon for its new Vantage Orian 1.5 Tesla MRI scanner. The scanner offers a 71cm wide bore and operates quietly due to its Pianissimo and Pianissimo Zen technologies. The Pianissimo has been proven to make sequences less noisy whilst the Pianissimo Zen can perform at noise levels which are nearly ambient. An immersive virtual experience named "MRI theatre" has been created: it links together video with audio so that a patient focusses on those elements rather than being scanned. This is a positive feature for younger people or patients that might feel uncomfortable undergoing such a procedure.
The new scanner has the ability to keep operating costs down whilst simultaneously maximising productivity. A new feature called “Rapid Scan” has been in-built which enables scans to be performed at faster rates than previously offered. Additionally, the “ForSee View” planning tool, helps to ensure rescanning won’t be required and other new technologies have been created so that a patient will not need to hold their breath when a cardiac and/or perfusion scan is taken.
Dominic Smith, senior director, CT, PET/CT and MR Business Units, Canon Medical Systems USA, Inc. said: