A Medical Device Daily

New European guidelines issued by the European Society of Cardiology (ESC; Sophia Antipolis, France) on the management of heart attack place emphasis on speed of action and the importance of reperfusion therapy to restore blood flow to the heart.

The new guidelines cover management of a common type of classical heart attack known as STEMI (ST-segment elevation acute myocardial infarction), a reference to its appearance on an ECG. Around one-third of all acute coronary events are diagnosed as STEMI.

Professor Frans Van de Werf from Leuven, Belgium, who chaired the ESC task force, describes the guidelines as "important" and says their broad uptake and adoption would make a "huge difference" to heart attack survival rates.

Although precise numbers are missing, it is thought that 30% to 50% of victims of heart attack die before reaching the hospital, most of them in the first hours after the onset of symptoms.

ESC said that while this fatality rate has remained fairly constant in recent years, survival rates in hospitals have markedly improved – from a rate of 75% in the 1960s to around 95% today. The introduction of coronary care units, new techniques of coronary intervention and treatments to dissolve blood clots all have improved in-hospital care.

The primary emphasis of the new guidelines – and the major changes since the previous edition of 2003 – relates to emergency systems and a speedy emphasis on reperfusion therapy, performed either by percutaneous coronary interventions (PCI) with balloon angioplasty and stent or thrombolysis treatment with clot-dissolving drugs.

The guidelines say the key to management, and thus to improved survival rates, is early diagnosis and risk assessment after first medical contact (FMC). Primary PCI is the "preferred treatment" if available within two hours of FMC.

If PCI is not possible within two hours, pre- or in-hospital thrombolysis should be performed as soon as possible after FMC — and within 30 minutes at the latest, according to the guidelines.

"Primary PCI is defined as angioplasty and/or stenting without prior or concomitant thrombolytic therapy, and is the preferred therapeutic option when it can be performed expeditiously by an experienced team," said the guidelines. The shorter the delay, the better the outcome – and FMC-to-balloon should be within two hours "in all cases."

The guidelines add that only hospitals with an established interventional cardiology program in operation 24/7 should use primary PCI.

Current registry data suggest that around 20% to 30% of all STEMI patients in Europe still receive no reperfusion therapy. However, he said adherence to the new guidelines could "dramatically" improve STEMI patient survival.

The guidelines also recommend that most patients following successful thrombolysis should be routinely referred for angiography to assess the condition of the coronary arteries and heart muscle.

The guidelines are being published in this month's edition of the European Heart Journal.

CE mark for Amedica's Valeo line

Amedica (Salt Lake City), an orthopedic implants company focused on silicon nitride ceramic technologies, said it has received the CE mark for its Valeo family of ceramic spinal intervertebral spacers.

This product line includes Valeo-C and Valeo-TL spacers made using Amedica's novel silicon nitride ceramic for surgical correction or stabilization of the spine. The products received FDA clearance in January for sale in the U.S. as vertebral body replacements.

The Valeo line of ceramic spinal intervertebral spacers is intended to aid in surgical correction and stabilization of the thoracolumbar spine. The company said the implants are designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time.

"The Valeo family of spacers provides new functionalities compared to competing devices currently on the market and is believed to be the first family of silicon nitride ceramic implants available for spinal use in the world," Amedica said in a press release.

Darrel Brodke, MD, professor and director of the spine service at the University of Utah School of Medicine's (also Salt Lake City) Department of Orthopedics, said, "Amedica's ceramic spinal spacers uniquely combine strength with an improved bone/implant interface and bone like imaging compatibility, making them a valuable alternative to currently available devices using conventional synthetic materials."

He added, "Because these implants have a combination of distinguishing features, I would expect Amedica's implants to be well received in Europe and Asia, where allograft bone is not frequently used."

Mutation detection kit added by DxS

DxS (Manchester, UK), a personalized medicine company and provider of companion diagnostics, reported the addition of a PI3K Mutation Detection Kit to its portfolio of oncogene mutation products.

The company said the PI3K-AKT pathway is activated in a variety of tumor types, resulting in cell growth and proliferation. Its PI3K Mutation Test Kit will detect four somatic mutations in exons 9 and 20 of the PIK3CA oncogene that often are found in a number of different cancers, including up to 40% of breast cancer.

DxS said the presence of these mutations "may influence the response to targeted therapies and prognosis, and screening for PI3K mutations using the DxS kit will aid researchers in determining these correlations."

Using its real-time PCR technology, Scorpions, DxS has developed what it said is "a highly sensitive and selective test to detect mutations at very low levels that can be performed in less than three hours."

The company said the assay is able to detect 1% of mutation in a background of wild-type genomic DNA, "and its unrivaled selectivity means that it highlights mutations often missed by sequencing methods."

CEO Dr. Stephen Little said, "This latest addition furthers our collection of Mutation Detection Kits and will help in the continued progression of personalized medicine in oncology."