Ischemic heart disease affects nearly 10 million Americans, and remains the leading cause of death among U.S. adults. This condition is most often due to a build-up of fat or plaque in the heart’s...
Cordis Corp. announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. Control Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or the...
Stryker announced the global commercial launch of the new Trevo ProVue Retriever. The Trevo ProVue Retriever is the first clot removal device fully visible during the procedure for precise...
The U.S. Food and Drug Administration (FDA) has granted market clearance for the Avinger Inc. Ocelot optical coherenace tomography (OCT) catheter to help cross...
The U.S. Court of Appeals for the Federal Circuit affirmed an April 2010 federal jury decision that Medtronic CoreValve LLC is willfully infringing Edwards Lifesciences' U.S. Andersen...
The U.S. Food and Drug Administration (FDA) granted market clearance for Cook Medical’s Zilver PTX drug-eluting peripheral stent. It is the first device of its kind on several fronts to go...
November 14, 2012 — Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Valiant Captivia stent graft system for the endovascular repair...
November 9, 2012 — Svelte Medical Systems announced it received conditional approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal study for the Svelte coronary stent...
November 9, 2012 — A study found that the use of rosuvastatin prior to angioplasty did not influence the levels of troponin I, a sensitive indicator of muscle damage. Results were presented at the...
November 8, 2012 — A hydration regimen tailored to the patient’s fluid status was effective in reducing damage to kidneys in patients undergoing cardiac catheterization, according to a study...
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...
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...
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...
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...
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...
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...
November 2, 2012 – A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared...
November 2, 2012 — Patients who receive a drug-eluting stent (DES) and demonstrate low levels of platelet inhibition are more likely to have blood clots form on the stent and suffer a possible...
Medtronic Inc. announced promising data from the Engager European Pivotal Trial for the investigational Medtronic Engager transcatheter aortic valve implantation (TAVI) system. The first results...
November 1, 2012 — Terumo Interventional Systems announced the nationwide availability of its new Pinnacle Precision Access System, a new vascular access system specifically designed for smooth,...
November 1, 2012 — InspireMD Inc. announced that its proprietary MGuard embolic protection stent (EPS) was shown to be significantly superior when compared to standard bare metal and drug-eluting...
Maquet Cardiovascular received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new Sensation Plus 7.5 French 40 cc...
W. L. Gore & Associates (Gore) responded to initial results reported in St. Jude Medical Inc.’s RESPECT clinical trial. The RESPECT study investigated whether transcatheter closure of patent...
Elixir Medical Corp. announced enrollment completion of the 120-patient, pivotal clinical trial evaluating the safety and efficacy of the DESolve Novolimus-Eluting...
October 29, 2012 — Brainlab released Buzz Digital OR, a major step forward in information integration for the surgical suite. Buzz encompasses a vast spectrum, from pure DICOM viewing to complete...
Covidien announced final 12-month results from its DEFINITIVE LE (Determination of Effectiveness of SilverHawk/TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal...
October 23, 2012 — In the DEBATE-SFA trial, researchers found that the use of a paclitaxel drug-eluting balloon (DEB) to widen the artery prior to implanting a self-expanding nitinol stent yielded...
The Transcatheter Cardiovascular Therapeutics (TCT) conference showcases key advancements being made in interventional cardiology, focusing this year on the next generation of drug-eluting stents...
October 19, 2012 — Volcano Corp. announced it has received both U.S. Food and Drug Administration (FDA) clearance and CE mark to market its new Visions PV .035 digital IVUS catheter in both...
Edwards Lifesciences announced today it received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards Sapien...
Infraredx Inc., a medical device company, and Royal Philips Electronics announced they have signed a joint development and collaboration agreement that is focused on integrating Infraredx’s true...
AngioDynamics said it entered into a definitive agreement to acquire all the outstanding capital stock of Vortex Medical Inc., a privately held company focused on the development of innovative...
October 16, 2012 — Proteon Therapeutics Inc. has initiated enrollment in a Phase 1 clinical study of its lead product, PRT-201, in patients with symptomatic peripheral artery disease (PAD) of the...
October 16, 2012 — The American Institute of Ultrasound in Medicine (AIUM) will host an Ultrasound First Forum on Nov. 12, 2012, in New York City. The forum will address the expanding role of...
Three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease from Cook Medical demonstrate 70.7 percent primary patency in the...
Surefire Medical Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its line of Surefire angiographic catheters. Surefire Medical will launch these products in...
October 12, 2012 — Boston Scientific announced it has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus valve system in up to 120...
October 11, 2012 — With this month’s approval of the Standards and Guidelines for Advanced Cardiovascular Sonography by the Commission on Accreditation for Allied Health...
Boston Scientific Corporation has begun the United States and European launch of its Victory guidewire, designed to facilitate crossing of resistant lesions and the placement and exchange of...
New research from the Netherlands suggests tiny microbubbles can be used to more effectively deliver a blood clot busting drug to patients while they are in the ambulance during acute heart attack...
October 8, 2012 — Simbionix USA Corp. will introduce the new advanced U/S (ultrasound) Mentor simulator at the upcoming American College of Emergency Physicians (ACEP) Exhibition in Denver, Colo....
Following Health Canada approval, Cook Medical has made the Zilver Vena Venous Self-Expanding Stent available to physicians across Canada. Designed to restore blood flow in obstructed iliofemoral...
October 8, 2012 — St. Jude Medical Inc. has launched MediGuide Technology, the first 3-D navigation system intended for the evaluation of vascular and cardiac anatomy on a recorded fluoroscopic...
Researchers at the University of Maryland School of Medicine, who are exploring novel ways to treat serious heart problems in children, have conducted the first direct comparison of the...
Aptus Endosystems Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its thoracic-length HeliFX Aortic Securement System. Similar to the original...
The National Institutes of Health (NIH)/National Cancer Institute (NCI) has awarded a five-year research project grant (R01) to identify harmonized reconstruction parameters for each currently-...
October 3, 2012 — Sharp Memorial Hospital was the first on the West Coast to participate in Medtronic's SYMPLICITY HTN-3 clinical trial in March, and is currently the leading trial site in ...
October 2, 2012 — AstraZeneca has announced the results from a sub-analysis of PLATO that evaluated the effects of age on clinical outcomes in patients with acute coronary syndrome (ACS). Results...
October 1, 2012 — CircuLite Inc. announced that the latest data from patients enrolled in the company’s CE mark trial of the Synergy Circulatory Support System strengthened prior findings...
The world’s first drug-eluting bioabsorbable vascular scaffold has been launched and will revolutionize the stent industry. On Sept. 25, 2012, Abbott announced the launch of its drug-eluting...
September 28, 2012 — Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) clearance for the Emerge percutaneous transluminal coronary angioplasty (PTCA)...
Medtronic Inc. announced it has received CE mark for its Medtronic CoreValve Evolut 23 mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system.
Boston Scientific has launched the Promus Element Plus BTK (Below The Knee) everolimus-eluting stent system in European countries for the treatment of certain severe peripheral artery lesions. The...
The American College of Cardiology (ACC) has certified Lumedx software as fully interoperable between four ACC NCDR registries. Lumedx, a leading provider of integrated cardiovascular imaging and...
Abbott Vascular began its international launch of the Absorb coronary stent, the world's first drug-eluting bioresorbable vascular scaffold (BVS). It is now widely available across...
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the saturated U.S. X-ray market will grow slowly to reach a value of $2.8 billion by...
The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the...
