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June 3, 2011 - Research presented at the International Federation of Clinical Chemistry Congress and Laboratory Medicine showed that using a lower diagnostic threshold for troponin improves clinical outcomes and patient survival in patients with suspected acute coronary syndromes. Troponin is a protein found inside heart cells that is released when they are damaged by ischemia or reduced blood supply.

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June 3, 2011 -- Maquet Cardiovascular announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its CardioRoot aortic graft in the United States. A one-piece design, aortic root graft, CardioRoot will be used by vascular and cardiovascular surgeons to surgically repair or replace diseased and damaged aortae. CardioRoot is now commercially available in the United States.

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June 3, 2011 – European CE mark approval was granted to expand use of the VerifyNow point-of-care P2Y12 test platelet reactivity test to identify patients who are poor-responders to antiplatelet therapy (e.g. clopidogrel).

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June 2, 2011 – The U.S. Food and Drug Administration (FDA) this week is warning medical professionals and U.S. medical device vendors to beware of possible safety concerns and radioactive contamination of medical devices and components coming from Japan.

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June 3, 2011 - In a two studies published recently in Heart Rhythm Society annual meeting, Investigators from the ...

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May 31, 2011 – Boston Scientific Corp. announced it is voluntarily recalling all of its iCross intravascular ultrasound (IVUS) coronary imaging catheters. The company said there have been several occurrences of the catheter tip detaching due to embrittlement of the catheter material.

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June 1, 2011 – If at first you don’t succeed, try, try again. That is what St. Jude Medical is doing after one court rejected its claims that Volcano Corp. developed an optical coherence tomography (OCT) intravascular imaging system using technology it took from St. Jude.

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May 26, 2011 - Ford engineers have developed a car seat that can monitor a driver's heartbeat, opening the door to a wealth of health, convenience and even life-saving potential. A joint project undertaken by experts from Ford's European Research and Innovation Centre in Aachen, Germany and Rheinisch-Westfalische Technische Hochschule (RWTH) Aachen University, the seat uses six special embedded sensors to detect electrical impulses generated by the heart.

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May 26, 2011 – AngioDynamics announced the launch of the new 90 cm NeverTouch procedure kit featuring a longer TRE-Sheath introducer to gain vascular access above the ankle for the treatment of varicose veins that extend below the knee. The new kit complements existing kit lengths of 25 cm, 45 cm and 65 cm, and rounds out the NeverTouch fiber product offering.

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May 26, 2011 – Cinterion, a cellular machine-to-machine (M2M) communication modules company, and TZ Medical, a manufacturer of critical-care medical products, announced Aera-CT, a lightweight and cost effective mHealth heart arrhythmia monitoring device (a Holter monitor). Equipped with the Cinterion MC75i module, the Aera-CT is expected to be commercially available in North America in Q3, 2011, followed by rolling launches throughout the world.

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May 26, 2011 - Carestream Health’s Vue Motion zero-footprint, Web-based enterprise viewer enables convenient on-demand access to imaging data and patient information by clinicians anytime, anywhere. This viewer’s support of mobile devices such as Apple iPads and tablet PCs is pending U.S. Food and Drug Administration (FDA) market clearance, but is available in other countries worldwide.

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May 25, 2011 – Boston Scientific Corp. today announced it received approval from the U.S. Food and Drug Administration (FDA) to market its 2.25 mm Promus everolimus-eluting coronary stent system for use in vessels as small as 2.25 mm in diameter. The company plans to immediately launch the product in the United States.

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The U.S. Food and Drug Administration (FDA) cleared the Xience nano everolimus-eluting coronary stent system for the treatment of coronary artery disease in small vessels. The Xience nano, which is based on the same platform as the Xience V everolimus-eluting coronary stent, offers physicians in the United States a new option for treating patients with coronary artery disease in vessels as small as 2.25 mm in diameter.

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May 24, 2011 - Cordis announced it has obtained CE mark for its Empira and Empira NC RX percutaneous transluminal coronary angioplasty (PTCA) dilatation catheters for the treatment of coronary artery disease. The Empira systems are designed to enable interventional cardiologists to open patients' narrowed coronary arteries during angioplasty and stenting procedures. The company also highlighted its radial access products at EuroPCR 2011.

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May 24, 2011 — Aptus Endosystems Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced CE mark approval for the Aptus EndoStapling System. The innovative helical staple technology enables independent endograft fixation, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms. Aortic aneurysms are an enlarged and weakened section of the aorta, which can be lethal if left untreated. Each year, an estimated 100,000 people in Europe and about 200,000 people in the U.S. are diagnosed with this condition. In EVAR, an alternative to open surgical repair, a metal and fabric endograft is implanted using a catheter-based delivery system to isolate blood flow away from the aneurysm to prevent potential rupture and death.

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