April 17, 2018 — The U.S. Food and Drug Administration (FDA) announced market approval for the Abbott Perclose ProGlide Suture-Mediated Closure System, designed to deliver a single suture to close the access sites in large vessels in the leg following catheterization procedures.

Philips Healthcare last week issued a proactive advisory warning to its iSite and IntelliSpace picture archiving and communication system (PACS) customers of potential security vulnerabilities in the products. The company cautioned that while it has received no reports of patient harm, the vulnerabilities in question could impact or potentially compromise patient confidentiality, system integrity and/or system availability.

The skin presents a formidable barrier to life-saving defibrillators, but a team of students from Rice University believes it has found a way around that problem.

Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.
OCT comparison of calcified coronary lesions treated with Shockwave lithoolasty, intravascular lithotripsy.

Over the last decade, there have been considerable developments in procedural techniques and technology facilitating the treatment of complex coronary artery disease (CAD). These were developed due to increasing burden of complex CAD encountered by interventional cardiologists as a consequence of an aging population who have greater burden of comorbidities. However, percutaneous coronary intervention (PCI) of calcified lesions continues to be one of the most challenging interventions, for which the optimal remedy remains elusive.

Medtronic plc announced U.S. Food and Drug Administration (FDA) approval to begin an investigational device exemption (IDE) pivotal trial to evaluate the Symplicity Spyral renal denervation system in patients with high blood pressure (hypertension). Renal denervation is a minimally invasive procedure intended to regulate the activity of nerves that lead to and from the kidney, which plays an important role in managing blood pressure. The SPYRAL HTN Pivotal Trial is part of the broader SPYRAL HTN Global Clinical Program, a multi-phased clinical study strategy aimed to establish the safety and efficacy of renal denervation to lower blood pressure.

Canon Medical Systems USA Inc. this week received U.S. Food and Drug Administration (FDA) clearance for the Aquilion Precision system, which it calls the world’s first Ultra-High Resolution computed tomography (UHR CT) system. The system can resolve anatomy as small as 150 microns and is designed to provide more than twice the resolution, typically seen only in cath labs. Containing an all-new detector as well as tube, gantry and reconstruction technologies, the system may make it possible to help expand visualization of disease thanks to new features that offer improved image detail.

April 13, 2018 — Medical advice about implanted cardiac defibrillators obtained via an online message board appears to be accurate only half of the time, according to new preliminary research. The research was presented at the American Heart Association’s (AHA) Quality of Care and Outcomes Research Scientific Sessions 2018, April 6-7 in Arlington, Va.

Biotronik U.S. and Aziyo announced a strategic agreement allowing Biotronik to distribute Aziyo's CanGaroo extracellular matrix (ECM) cardiovascular implantable electronic device (CIED) envelopes in the United States. BioEnvelope will be available from Biotronik starting in April 2018.

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