
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.
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.
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.
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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.
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.
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.
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
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.
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.
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.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
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.
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).
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
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
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.
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.
The U.S. Food and Drug Administration (FDA) accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health. ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.