Terumo Medical Corp. is recalling the SoloPath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim of the sheath. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Marvin Eng, M.D., structural fellowship director at Henry Ford Health System, and William O'Neill, M.D., director of the Henry Ford Hospital structural heart program, explain the mitral valve repair program at Henry Ford. The hospital performs a large number of transcatheter mitral valve repairs, including MitraClip, and is involved in trials for investigational device technologies.

A discussion with William O’Neill, M.D., director of the Henry Ford structural heart program, Ruth Fisher, MBA, vice president of the program, and Janet Wyman, NP, program manager. Henry Ford Hospital has built a large, high-volume structural heart program that includes use of cutting edge new technologies and devices.

Iodine-based CT contrast with ready for scanning with a Canon Aquilion One 320-slice CT system at Northwestern Medicine Central DuPage Hospital in the Chicago suburbs. It is not clear that contrast caused contract induced nephrapathy (CIN), also referred to as acute kidney injury (AKI) or contrast-associated acute kidney injury (CAAKI). Photo by Dave Fornell

Iodine-based contrast agents used in computed tomography (CT) and catheter-based angiography have been implicated as a cause of contrast-induced nephropathy (CIN). This has raised concern in recent years, especially in renally compromised patients, and imagers are looking for ways to reduce the contrast media dose levels they use.

Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is Sept. 28, 2019. Because of the Priority Review designation, the timing of this PDUFA date is four months earlier than the anticipated standard ten-month review for applications.

Philips announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT). These two trials are part of a series of five trials evaluating the safety and efficacy of Stellarex .035″ low-dose1 drug-coated balloon (DCB) to restore and maintain blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to treatment with uncoated balloons, the current standard of care.

As part of the Consolidated Appropriations Act of 2018, pass-through payment status for LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use has been extended for an additional two years. This extension became effective Oct. 1, 2018 and will remain in effect through Sept. 30, 2020.

Corindus Vascular Robotics Inc. announced its CorPath GRX System was successfully used to perform a live complex robotic-assisted percutaneous coronary intervention (PCI) at the EuroPCR 2019 Conference, May 21-24 in Paris, France.

New data demonstrated that use of the investigational HeartFlow Planner, a real-time, non-invasive interactive planning tool, led to a change in treatment strategy in 45 percent of patients with coronary artery disease (CAD) and reduced the need for invasive physiology. The data from the BOWIE (Benefits of Obtaining information for planning With noninvasive FFRCT prior to Invasive Evaluation) study were presented by Eric Van Belle, M.D., Ph.D., professor of cardiology, head of the Lille Heart & Lung Institute, and principal investigator for BOWIE, as a late-breaking trial at the EuroPCR Conference, May 21-24 in Paris, France. The results were also published in the Journal of the American College of Cardiology (JACC).

Physicians use many strategies to better interface with patients and their families to try and explain in non-physician terms basic cardiac conditions and how the various subspecialties are involved. My favorite is the analogy of cardiac conditions related to owning an old house and all the issues the homeowner can face, including plumbing issues, electrical issues and structural issues. As an owner of a house built in the 1890s and finding myself doing the majority of the constant repairs, I found these comparisons to be spot on.

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