ART, PBS, pure bioresorbable scaffold, CE Mark

Privately-held company Arterial Remodeling Technologies (ART) announced CE Mark clearance for its next-generation drug-free, pure bioresorbable scaffold used to treat coronary artery disease. The CE Mark was achieved following the completion of extensive pre-clinical research — this included up to three-years of follow-up, and supportive clinical results from leading coronary angioplasty centres such as the Hôpital Européen Georges Pompidou in Paris and investigators such as Jean Fajadet, M.D., at the Clinique Pasteur in Toulouse.

At EuroPCR 2015, Mitralign presented updates on its mitral and tricuspid valve repair systems, including a presentation on six-month data on its Mitral system.

Edwards Lifesciences Corp. announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the SAPIEN 3 transcatheter aortic valve demonstrated very low mortality and stroke rates, and no severe paravalvular leaks. These independently adjudicated data from centers in Europe and Canada are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. The study was presented at EuroPCR 2015 by Alec Vahanian, M.D., chair of the cardiology department at Bichat University Hospital, Paris.

St. Jude Medical Inc. announced preliminary results from the ILUMIEN I trial and final results from the ILUMIEN II clinical study. Taken together, the findings from both studies show that with resolution up to 10 times higher than intravascular ultrasound (IVUS), optical coherence tomography (OCT) imaging can help improve stent selection and deployment, better support clinical decision-making and improve patient outcomes.

Orlando Health recently successfully unrolled Lumedx’s physician structured reporting and image management solution across five of its campuses. The implementation was smooth and swift, user adoption is 100 percent, and the benefits are manifold.

The biggest technology news coming out of the 2015 American College of Cardiology (ACC) annual scientific sessions involved the overwhelmingly positive late-breaking trial data for transcatheter aortic and mitral valve repair. ACC dedicated an entire day of late-breaking trial presentations to this new technology, highlighting its importance in how cardiology will be changing in the coming years, moving from invasive surgical repairs to minimally invasive percutaneous therapies. There were reservations a couple years ago among most cardiologists that transcatheter procedures would not live up to the durability and outcome standards set by surgical valve replacement, but data continue to show it is comparable, and in some cases, better. 

According to a new study, small changes in quality improvement procedures enabled clinicians to use magnetic resonance imaging (MRI) scans to diagnose stroke patients before giving acute treatment, within 60 minutes of arrival. MRI scans provide detailed images but take longer to complete than computed tomography (CT) scans, which are commonly used in most centers.

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