FDA US device innovation
Feature | Anita Asgar, M.D., FSCAI

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies regarding clinical trials and device approval. This concern was the subject of keynote addresses by Jeffrey Popma and Robert (Chip) Hance at the 2013 SCAI Scientific Sessions.

Home July 03, 2013
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cath lab, SYNTAX, SCAI
Feature | Dmitriy N. Feldman, M.D., FACC, FSCAI

The year 2013 has brought us several important clinical trials that have changed the way interventional cardiologists approach and treat patients with stable coronary artery disease. These trials were a major focus at the “Hottest Topics 2013” session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2013 Scientific Sessions

Home July 03, 2013
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Medstreaming launched its new Graphic Based Surgical Application for desktop and mobile platforms at the Vascular Annual Meeting (VAM) May 30 – June 1, 2013 in San Francisco. The structured operative note application uses anatomical sketches to enable surgeons and interventionalists to easily generate structured reports based on graphical workflow.

Home July 02, 2013
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UltraSPECT, a leading provider of nuclear medicine (NM) image reconstruction technology that reduces radiopharmaceutical dose and acquisition time, announced the installation of its proprietary Wide Beam Reconstruction (WBR) software at nearly ten healthcare facilities. These installations come as a result of the recent agreement between UltraSPECT and radiopharmaceutical provider PharmaLogic, under which PharmaLogic is offering the WBR software as part of its patient-centered approach. In just a short time, PharmaLogic has successfully approached dozens of NM imaging facilities about the advanced WBR software which improves patient safety and technologist safety, while providing higher efficiency and optimum image quality.

Home July 01, 2013
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One-year data from an Italian multicenter randomized controlled trial of the In.Pact Falcon drug-eluting balloon from Medtronic Inc. demonstrate positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries, according to a presentation made at EuroPCR.

Home July 01, 2013
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Primary end-point results from the BIOFLOW-II clinical study demonstrating the non-inferiority of the Biotronik Orsiro Hybrid Drug-Eluting Stent compared to Abbott's Xience Prime. These results were presented in a late-breaking clinical trials session at the EuroPCR congress in Paris by principal investigator, Professor Stephan Windecker, M.D. of University Hospital Bern, Switzerland.

Home July 01, 2013
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Technology

June 28, 2013 — Maquet Cardiovascular LLC announced it has acquired LAAx Inc., a privately held company that has developed a unique mechanical occlusion device called the TigerPaw System II. When implanted, TigerPaw II safely and effectively occludes the left atrial appendage (LAA).

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June 28, 2013 — St. Jude Medical Inc. announced CE mark approval of its next-generation quadripolar device, the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D).

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Sorin Group announced the results of the DREAM clinical trial. In this study, the sleep apnea monitoring (SAM) algorithm of Sorin Reply 200 pacemakers was validated against polysomnography, the gold standard method used to measure the severity of sleep apnea (SA). Initial data show that Reply 200 with the new SAM algorithm provides reliable screening for the risk of severe SA[1].

Home June 27, 2013
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Validating its shock reduction research and technology, Medtronic Inc. announced the results of three clinical trials, Shock-Less, PainFree SST and ADVANCE III, which successfully employed key strategies to dramatically reduce inappropriate and unnecessary shocks in patients with implantable cardiac defibrillators (ICD). The studies followed more than 7,000 patients on six continents; results were presented at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.

Home June 26, 2013
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Boston Scientific Formio Vitalio Inliven Pacemakers EP Lab
Feature

Boston Scientific Corporation is launching a new family of pacemakers in Europe. These pacemakers monitor respiration, adjust pacing accordingly, and support insight into the patient's overall heart failure status. Comprising of the Inliven cardiac resynchronization therapy pacemaker (CRT-P) that synchronizes the heart chambers, and the Vitalio and Formio pacing systems, the new family of devices offers clinicians a comprehensive set of tools for the management of heart failure and related comorbidities.

Home June 26, 2013
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Technology

Digisonics will exhibit its No. 1 KLAS rated cardiology picture archive and communications system (PACS) and structured reporting solutions at this year’s American Society of Echocardiography (ASE) Scientific Sessions in Minneapolis, Minn.

Home June 25, 2013
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Technology

June 25, 2013 — Siemens Healthcare announced that the U.S. Food and Drug Administration (FDA) has cleared the Virtual Touch imaging ultrasound application, Siemens’ first commercially available implementation of Acoustic Radiation Force Impulse (ARFI) technology.

Home June 25, 2013
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More than 54 companies will display their latest products and services at the American Society of Echocardiography’s (ASE) 24th Annual Scientific Sessions, planned for June 29-July 2 at the Minneapolis Convention Center in Minneapolis, Minn. This year, the conference theme is “a disease-based focus on the role of echocardiography in diagnosis and guiding therapy”.

Home June 25, 2013
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June 25, 2013 — Zoll Medical Corp. announced that a paper published in Critical Care Medicine reported the likelihood of achieving a return of spontaneous circulation (ROSC) after sudden cardiac arrest (SCA) is 62 percent greater when the AutoPulse noninvasive cardiac support pump is used to deliver CPR chest compressions.

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