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November 7, 2012 — Kona Medical Inc. announced the initiation of the first clinical study of its device therapy for drug-resistant hypertension. The company is sponsoring the WAVE I clinical study to evaluate the safety and efficacy of its novel technology, and is now enrolling subjects at St. Vincent’s Hospital in Melbourne, Australia, under the direction of primary investigator Robert Whitbourn, M.D.

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November 7, 2012 — Micell Technologies Inc. announced positive data from two clinical studies of its investigational MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES), a thin-strut drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating designed to control drug release.

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November 7, 2012 — Athera Biotechnologies AB announced that results from a new study were presented at the Pacific Northwest Vascular Society Annual Meeting in Vancouver, Canada. The data shows that low levels of plasma anti-PC, measured with Athera’s CVDefine kit, are associated with a high risk for vein graft failure after bypass surgery.

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Technology

Janssen Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment.

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November 6, 2012 — A study has found several benefits in using the radial artery in the arm as the entry point for angioplasty or percutaneous coronary intervention (PCI) compared to the femoral artery in the leg. Results of the STEMI-RADIAL trial were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

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Corindus CorPath robotic system
Feature | By Dave Fornell

Hospitals constantly try to predict what the future holds when planning new facilities and equipment purchases that need to last for the next decade. Martin Leon, M.D., attempted to answer that question for interventional cath lab technologies during Transcatheter Cardiovascular Therapeutics (TCT) 2012, making predictions through 2020.

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November 6, 2012 — Vascular Solutions launched the R-Band radial hemostasis compression device in the United States. Vascular Solutions is the exclusive distributor of the R-Band device in the United States under an agreement entered into with Lepu Medical Technology (Beijing) Co. Ltd.

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November 6, 2012 — Toshiba America Medical Systems Inc. has expanded its Assurance Program to offer reconditioned Toshiba ultrasound systems. Assurance ultrasound products include AplioTM XG, Aplio MX, Aplio Artida, Viamo and Xario XG. All come with a 12-month warranty.

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The Philips Healthcare Ambient Experience integrates architecture, design and enabling technologies, such as dynamic lighting and sound, to allow patients and staff to personalize their environment to create a relaxing atmosphere. Patients are able to select room themes and sounds, empowering them to be involved in their own care. Concurrently, Philips’ designers take special care to address the needs of the clinical staff to make their workplace efficient and pleasant.The Ambient Experience uptake room can help reduce patient anxiety, improve workflow and patient care. The uptake room solution is a stylishly designed ceiling unit that generates specifically created mood settings with practical procedure light and audio settings for an excellent staff working environment. It transforms a standard uptake room into one that changes according to the various workflow steps. In this way, it fully supports the tasks performed by staff and reduces patient anxiety at the same time.The solution includes:Practical procedure light and audio settings for an excellent staff working environmentSpecific task light to facilitate FDG (a radiopharmaceutical used in medical imaging) injectionActive relaxation video content and light settings – with emphasis on the first 25 minutes of the uptake periodFor more information: www.philips.com

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A new report by the Harvey L. Neiman Health Policy Institute shows that the length of the average hospital stay in the United States has increased at the same time as use of medical imaging scans has declined. It is unclear if the trends are related, but potentially important, as hospital admissions are among the largest, and fastest growing, healthcare costs. More research is needed to assess the potential negative impact of government and private insurer imaging reductions on overall medical costs and patient safety.

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Videos | Structural Heart Occluders

Positive results from the RESPECT Trial of transcatheter patent foramen ovale (PFO) closure vs. standard medical therapy ...

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Medtronic Inc. announced new findings from the Medtronic CoreValve ADVANCE Study for one-year survival and health-related quality of life (HRQoL). The findings were presented at Transcatheter Cardiovascular Therapeutics (TCT) Meeting 2012 in Miami.

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Edwards Sapien Valve Partner Clinical Trial Heart Valve Repair
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Edwards Lifesciences Corporation announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve. The data from The PARTNER Trial (Cohort B) demonstrated a sustained and increasing survival benefit for Sapien valve patients at three years, as well as significantly less time spent in the hospital. The new results were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

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November 5, 2012 — ReCor Medical reported one-year follow-up data on patients who have been treated via renal denervation for their resistant hypertension with the company’s Paradise System — the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency energy.

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DISCOVER Clinical Trial Direct Medical Trial Direct Flow Medical Transcatheter
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Direct Flow Medical Inc. announced that its DISCOVER CE mark trial met its primary mortality endpoint. The study also demonstrated that greater than 95 percent of patients had mild or less aortic regurgitation, and no patients experienced vascular complications. The DISCOVER Trial results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami, Fla.

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