December 27, 2012 — Biotronik announced that the first implant has taken place in the BIOHELIX-I trial in the United States. The BIOHELIX–I trial is set to evaluate the safety and performance of the Pro-Kinetic Energy coronary bare metal stent.

According to Millennium Research Group (MRG), a company focused on global medical technology market intelligence, approximately 80 percent of transcatheter aortic valve replacement (TAVR) procedures are being performed on high-risk patients who are ineligible for surgical heart valve replacement. New clinical evidence that supports TAVR in treatment of intermediate and high-risk operable patients has led to expanded reimbursement for a new patient base for the procedure. The inclusion of these patients will fuel much of the growth of the TAVR market in Europe over the next four years. The market will grow by 60 percent between 2012 and 2016, following 30 percent growth from 2011 to 2012. The European TAVR market will have a total value of $650 million dollars by 2016.

A dozen years ago, controversial clinical trial results caused an international medical society to warn against the use of stents in leg arteries. But recent years have brought significant improvements in stent technology. One-year follow-up results of a worldwide, multicenter trial with 744 patients show that 90 percent of participants had successful procedures that did not require a repeat treatment.

December 26, 2012 — St. Jude Medical Inc. announced the first patient enrollment in its ILUMIEN I clinical study. The observational study is designed to show the optimal way optical coherence tomography (OCT), combined with the PressureWire Aeris, a wireless interventional tool that measures fractional flow reserve (FFR), can guide stent implantation in patients with coronary artery disease.

December 26 , 2012 — Congress last week affirmed its dedication to securing a sustainable, domestic supply of molybdenum-99 (Mo-99) as it passed the American Medical Isotope Production Act of 2011 (S.99). The bill, sponsored Sen. Jeff Bingaman (D-N.M.), chair of the Senate Committee on Energy and Natural Resources, and Sen. Lisa Murkowski (R-Ark), was passed out of the Senate by Unanimous Consent and referred to the House Subcommittee on Energy and Environment. S.99 was included in the Conference Agreement for the National Defense Authorization Act for fiscal year 2013. The president is expected to sign the final legislation.

December 26, 2012 — Flexible Stenting Solutions Inc. (FSS) announced it gained CE mark in the European Union for its 6 French Reconstrainable FlexStent Femoropopliteal self-expanding stent system. FSS is a developer of next-generation peripheral, neurovascular and biliary stents. This new device combines advanced FlexStent technology with unique reconstrainable stent delivery technology.

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