DAIC Articles

Oct 31, 2019 | DAIC Articles
IVUS Better Than Venography to Identify Venous Stent Landing Zones

In a large series of iliac vein stent cases, a blinded comparison found intravascular ultrasound (IVUS) superior to venography in determining the proper location of treatment zones. This is reported in the November 2019 edition of the Journal of Vascular Surgery: Venous and Lymphatic Disorders.[1]

Oct 31, 2019 | DAIC Articles
2-French Electrophysiology Catheter Introduced by Baylis Medical

Baylis Medical announced the first North American use of its EPstar Fixed Electrophysiology Catheters. The EPstar catheters make available the smallest diagnostic catheter in the North American electrophysiology market, allowing physicians to reach previously inaccessible areas of the heart for procedure mapping.

Oct 29, 2019 | DAIC Articles
Siemens Completes Acquisition of Cath Lab Robotics Vendor Corindus

October 29, 2019 — Siemens Healthineers completed the acquisition of 100 percent of Corindus Vascular Robotics Inc., effective Oct. 29, 2019. Prior to the closing of the acquisition, Corindus held a shareholders’ meeting Oct. 25, at which 87.5 percent of their stockholders approved the acquisition. The relevant governmental authorities previously granted the approvals required to […]

Oct 28, 2019 | DAIC Articles
Gore Receives European Approval For Cardioform ASD Occluder For Atrial Septal Defects

October 28, 2019 — The Gore Cardioform ASD Occluder received European CE mark clearance in early October. The device offers a percutaneous, transcatheter closure option for the ostium secundum atrial septal defects (ASDs).

Oct 28, 2019 | DAIC Articles
Canon Medical Offers New Affordable Interventional Technology

Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors. The Alphenix Aero Edition from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Oct 23, 2019 | DAIC Articles
BioCardia Initiates Commercial Release of Avance Steerable Introducer

October 23, 2019 — BioCardia announced the U.S. commercial availability of its Avance Bi-Directional Steerable Introducer Sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September.

Oct 21, 2019 | DAIC Articles
FDA Approves Coronary ViperWire Advance With Flex Tip

October 21, 2019 — Cardiovascular Systems Inc. recently announced U.S. Food and Drug Administration (FDA) premarket approval (PMA) of the new ViperWire Advance Coronary Guide Wire with Flex Tip (ViperWire Advance with Flex Tip).

Oct 11, 2019 | DAIC Articles
FDA Issues Final Guidances on Guidewires, Intravascular Catheters and Delivery Systems

October 11, 2019 — The U.S. Food and Drug Administration (FDA) issued two final guidances for the performance testing and labeling of cardiac catheterization lab devices.

Oct 11, 2019 | DAIC Articles
Supraflex Drug-Eluting Stent Superior to Xience in Two-Year Target Vessel Failure

October 11, 2019 — The ultra-thin Supraflex drug-eluting stent (DES) from SMT maintained numerically lower outcomes at two years of follow-up in a randomized trial against Abbott’s Xience stent, according to results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019, Sept. 25-29 in San Francisco.

Oct 10, 2019 | DAIC Articles
LEVANT Trial Data Shows Safety of Drug-Coated Balloon Shown

October 10, 2019 — An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no statistically significant mortality increase. This was one of the first major reviews of trial data for patients who were treated with a paclitaxel coated device used in peripheral vessels following a meta analysis study of paclitaxel device trials […]