Intact Vascular Inc. announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and European investigational device exemption (IDE) clinical trial of the Tack Endovascular System.
Kimihiko Kichikawa, M.D., department of radiology at Nara Medical University in Japan, reported two-year results of the Zilver PTX post-market surveillance (PMS) study at the 2015 Cardiovascular and Interventional Radiology Society of Europe (CIRSE) meeting in Lisbon, Portugal. Kichikawa’s presentation focused on initial target data on lesion revascularization (TLR).
Stentys announced that the company’s drug-eluting stent received CE Mark for treatment of below-the-knee (BTK) arteries. The approval makes it the first self-expanding and drug-eluting stent with regulatory approval in Europe for this indication.
October 1, 2015 — Infinitt North America will feature the Infinitt Healthcare Platform (IHP) at RSNA 2015. This centralized archive solution provides open, standards-based storage and manages DICOM and non-DICOM data over their life cycle regardless of where the data originated, and making it easier and more cost-efficient to comply with retention policies and security regulations.Â
October 1, 2015 — The first and only system that delivers real-time X-ray radiation dose monitoring for physicians and clinicians will be featured at Radiological Society of North America (RSNA) 2015 annual meeting. The RaySafe i2 is an active dosimetry system that enables effective behavior change by showing physicians and staff their real-time dose during live procedures.