FDA Recommendation Lutonix Drug Coated Balloon Catheter

C. R. Bard Inc. announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB) in the United States.

New appropriate use expert consensus documents developed by the Society for Cardiovascular Angiography and Interventions (SCAI) provide guidance on treating the most common form of peripheral artery disease (PAD), namely blockages that affect arteries above the knee. 

June 16, 2014 — PolyNova, a startup company that has grown out of an inter-institutional collaboration between the University of Arizona (UA) and Stony Brook University, announced it is developing a novel polymeric prosthetic heart valve. Sarver Heart Center cardiologist Marvin J. Slepian, M.D., professor of medicine and biomedical engineering at the UA, is the founding CEO of the new venture. PolyNova entered an exclusive option to the patent rights jointly held by the two universities earlier this spring.

June 16, 2014 — Carestream’s Smart Link helps ensure optimal system performance and uptime by continuously monitoring operations of its healthcare IT and digital imaging systems at healthcare providers across the globe. Smart Link is provided as part of Carestream’s customer service maintenance agreements.

June 16, 2014 — Boston Scientific Corp. has initiated the RESPOND post-market registry to assess real-world performance of the Lotus valve system. The RESPOND registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centers around the world.


June 16, 2014 — Children with heart disease are exposed to low levels of radiation during X-rays, which do not significantly raise their lifetime cancer risk. However, children who undergo repeated complex imaging tests that deliver higher doses of radiation may have a slightly increased lifetime risk of cancer, according to researchers at Duke Medicine. The findings, published June 9 in the American Heart Association (AHA) journal Circulation, represent the largest study of cumulative radiation doses in children with heart disease and associated predictions of lifetime cancer risk.

Medtronic announced it is purchasing Covidien in a cash-and-stock deal for $42.9 billion. Once the transaction is completed, Medtronic will have significantly advanced its position as a premier international medical technology and services company. 

Cardinal Health announced the 2 millionth shipment of the Mynx Vascular Closure Device (VCD).

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