International healthcare-focused merger and acquisition (M+A) advisory firm Vertess recently shared its vision of how a new healthcare plan from President-elect Donald Trump could impact the healthcare industry.

EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results of the EXCEL (Evaluation of Xience versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) Trial, which compared the latest generation Xience V drug-eluting stents (DES) to coronary artery bypass surgery (CABG).[1] The result of the 1,905-patient study was that both revascularization strategies have comparable outcomes using the latest techniques and technology in patients with a blockage in the left main coronary artery.

January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Administration Sets used in nuclear imaging. The company said particulates can form inside the vials. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.

The company is recalling all product distributed between Oct. 9, 2008 to Oct. 11, 2016. This includes 86,172 products in the U.S. 

According to a recent study by the Harvey L. Neiman Health Policy Institute, the last two decades have seen a substantial decline in new enteral access procedures in the Medicare population. The study, published online in November in the Journal of Vascular and Interventional Radiology (JVIR), also found that maintenance services have increased, with radiologists and emergency physicians surpassing gastroenterologists and surgeons as the leading providers of those procedures.

January 11, 2017 — Lombard Medical Inc. recently announced approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex Low Profile (LP) Delivery System for the Aorfix Endovascular Stent Graft. Commercial launch will follow reimbursement approval, which is anticipated in February 2017.

For patients with atrial fibrillation, the most common form of heart arrhythmia, a main goal of treatment is stroke prevention. As a result, most Afib patients are prescribed a blood thinner such as warfarin, also known by the brand name Coumadin, to combat the potential for blood clots that could lead to stroke. But warfarin is tough to manage, and some patients have trouble adhering to any medication. A new research letter published in JAMA Cardiology finds Afib patients are even more likely to discontinue warfarin therapy if they’ve had a recent procedure done to address their arrhythmia.

January 11, 2017 — Avinger Inc. recently announced the U.S. launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images to physicians using Avinger’s Lumivascular system, the first-ever image-guided atherectomy and chronic total occlusion (CTO) recanalization devices for the treatment of peripheral artery disease (PAD), providing physicians with a view inside diseased arteries.

BioVentrix Inc. announced in December the first closed-chest Revivent TC TransCatheter Ventricular Enhancement System procedure in Germany since receiving CE mark certification. The Less Invasive Ventricular Enhancement (LIVE) procedure was performed by interventional cardiologists Christian Frerker, M.D. and Tobias Schmidt, M.D., and by cardiothoracic surgeon Ralf Bader, M.D., at Asklepios Klinik St. Georg in Hamburg, Germany.  The St. Georg Heart team is led by Prof. Dr. Karl-Heinz Kuck, who is also the chairman of the Department of Cardiology and Electrophysiology.

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