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Cardiac surgeons and cardiologists at the University of Maryland Heart Center are part of a multi-center clinical trial evaluating the efficacy of powering heart pumps through a skull-based connector behind the ear. Typically, these devices for patients with severe heart failure are energized through an electrical cord connected at an abdominal site.

Home August 20, 2013
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August 19, 2013 — Medtronic Inc. announced the submission of its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon.

Home August 19, 2013
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Cook Medical is again shipping its Zilver PTX drug-eluting peripheral stent to medical centers in the United States, Japan, Europe and other major markets. The shipments follow a brief period of unavailability due to a voluntary recall by Cook related to an issue with the stent’s delivery catheter that has been resolved.

Home August 19, 2013
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IMRIS Inc. announced that a craniotomy recently performed on a 5-year-old boy with epilepsy was the 500th neurosurgical case at Cook Children's Medical Center in Fort Worth, Texas, using its intraoperative magnetic resonance imaging (iMRI) system. Cook Children's was the second children's hospital in the United States and fourth hospital worldwide with an IMRIS system that features a high-field MRI, which moves between surgical and diagnostic rooms using ceiling-mounted rails.

Home August 19, 2013
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Aplio 500 received top ranking in the Ultrasound – General Imaging category in the 2013 Best in KLAS Awards: Medical Equipment & Infrastructure.

Home August 16, 2013
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Patient enrollment has been initiated in a post-market registry for the Combo Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent — Combo Bio-Engineered Sirolimus Eluting Stent — Post Market Registry) will enroll 1,000 patients at nine European sites. As of today, more than 100 patients have already been enrolled.

Home August 16, 2013
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Former President George W. Bush underwent heart surgery on the morning of Aug. 6, 2013, to receive a stent after an artery blockage was discovered during his annual physical. The routine physical included a stress test and an electrocardiogram. Abnormal results from the stress test prompted the former president to receive a computed tomography (CT) angiogram, and the surgery successfully took place one day after the blockage was discovered.

Home August 15, 2013
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The first implantation of Tyrx Inc.’s new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., by Christopher R. Ellis. The AigisRx R Antibacterial Envelope received U.S Food and Drug Administration (FDA) clearance on May 20, 2013.

Home August 15, 2013
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Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility study is continuing, and early clinical results from the second implantation of the Colibri device confirm the positive clinical findings observed in its first use. The Colibri transcatheter aortic valve implantation (TAVI) system is the first low profile, 14 French, pre-mounted, pre-crimped, and pre-packaged, ready-for-use TAVI system.

Home August 14, 2013
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IMRIS Inc. has obtained regulatory CE mark for Visius iCT, the first and only ceiling-mounted intraoperative computed tomography (CT), allowing for sales and marketing in the European Union.

Home August 13, 2013
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The William Stamps Farish Fund in Houston has donated $400,000 to a collaboration between the Institute for Computational Engineering and Sciences (ICES) at The University of Texas at Austin and the Texas Heart Institute (THI) to study life-threatening vulnerable plaques, the cause of at least two-thirds of all heart attacks, and new ways to prevent them.

Home August 13, 2013
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Technology

August 12, 2013 — Ambio Health, a healthcare technology company specializing in health monitoring systems, announced its Ambio remote health monitoring system, a wireless remote health and activity monitoring tool, received Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA).

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Positron Corporation entered into a multi-year radioisotope supply agreement with iThemba LABS of Cape Town, South Africa. The supply agreement contracts the procurement of raw material, strontium-82 (Sr-82) from iThemba LABS for further production of the active pharmaceutical ingredient (API) at Positron's radioisotope production facility in Lubbock, Texas. In September 2013, Positron will receive relevant volumes of strontium-82 for qualification and will commence with commercial availability beginning in February 2014. This additional supply will enhance the industry's strontium-82 supply and increase the availability of radiopharmaceuticals to the end user. Positron intends to make this Sr-82 API supply available to all rubidium-82 generator producers in the marketplac

Home August 09, 2013
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Technology

NDS Surgical Imaging (NDSsi) has released its DomeAccess remote picture archive and communication systems (PACS) management software tool. DomeAccess software allows users to manage their Dome diagnostic display workstations from anywhere in the world.

Home August 08, 2013
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Sorin Group has received 510(k) clearance for commercialization of Sorin Connect, Sorin Group’s perfusion electronic charting system. The new Sorin Connect perfusion electronic charting system allows real-time data recording and trends visualization aimed to support clinicians and institutions in their perfusion management and documentation goals, during and after cardiac surgery.

Home August 08, 2013
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