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.

French medical technology company CorWave announced it has been awarded almost $3.5 million in financing for its R&D program NovaPulse in the Silver Economy category. This is part of phase 2 of France’s Concours Mondial d'Innovation or Worldwide Innovation Challenge.

Women who give birth to infants with congenital heart defects may have an increased risk of cardiovascular hospitalizations later in life, according to new research in the American Heart Association’s journal Circulation.

Medtronic plc announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance Cryoballoon to isolate the pulmonary veins in patients with symptomatic persistent atrial fibrillation (AF). The Arctic Front Advance Cyroablation System is not approved for treating persistent AF in the United States.

 

The biggest workplace concern for interventional cardiologists and cath lab staff is their daily exposure to ionizing radiation from the angiographic X-ray systems that are central to their procedures. In addition to increased cancer risks and developing cataracts, they are also worried about orthopedic issues caused by wearing heavy radiation protection aprons, which takes a toll on the spine and can lead to chronic back problems.

Abbott today announced the initiation of a clinical trial evaluating long-term outcomes of patients who undergo stent implantation guided by  optical coherence tomography (OCT) compared to angiography. The trial (ILUMIEN IV) is the first large-scale randomized global study using Abbott's OCT imaging in patients with high-risk, complex coronary artery disease. Patients in the study will be randomized to either OCT-guided or traditional angiography to guide placement of one or more Xience everolimus-eluting coronary stents.

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