News

February 14, 2011 – Acute ischemic stroke hospitalizations among middle-aged and older men and women fell between 1994 and 2007, but sharply increased among those under age 35 – including teens...

February 14, 2011 – A new bedside insertion kit and power-injectable catheter has been launched. The Morpheus Smart PICC insertion kit and 5 French Dual Lumen Peripherally Inserted Central...

February 11, 2011 – The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has launched the Medical Device Innovation Initiative. The initiative proposes...

February 10, 2011 – A Phase 2 clinical trial has been initiated to test the safety and efficacy of drug to reverse heparin in patients undergoing percutaneous coronary intervention (PCI). The...

February 9, 2011 – The first patients have been enrolled in a trial investigating the safety and efficacy of a system that removes clot from acute ischemic stroke patients. The Trevo 2 study will...

February 9, 2011 – The U.S. District Court for the District of Delaware reaffirmed an April 2010 federal jury decision that determined Medtronic CoreValve LLC willfully infringed Edwards...

February 9, 2011 – The U.S. Food and Drug Administration (FDA) said certain lots of the Arstasis One femoral artery access system are part of a Class 1 recall. Components of the device may...

February 9, 2011 – A partnership has been formed to launch a portable therapeutic cooling system in Europe. Physio-Control and BeneChill will work together to launch the RhinoChill IntraNasal...

February 8, 2011 – The U.S. Food and Drug Administration (FDA) said Merit Medical Systems initiated a Class I recall for one lot of its Prelude Short Sheath Introducer, because the tips may detach...

February 7, 2011 – There is a tremendous unmet need for new medical technologies to treat potentially dangerous chronic venous insufficiency (CVI) and blood clots, according to a Scientia Advisors...

February 7, 2011 – A rare and often underreported form of stroke involving veins instead of arteries is more common than previously thought, according to the American Heart Association's (AHA)...

February 4, 2011 – More heart disease tests do not necessarily add up to a better diagnosis. According to a new practice guideline, a basic risk assessment that accounts for such factors as...

February 4, 2011 – Researchers at the National Institutes of Health's (NIH) Undiagnosed Diseases Program (UDP) have identified the genetic cause of a rare and debilitating vascular disorder not...

February 3, 2011 – Widespread screening or routine ultrasound for blocked neck arteries to determine stroke risk isn't necessary, according to new guidelines from the American Heart Association/...

January 31, 2011 – Volcano Corp. said today the Superior Court of Massachusetts issued a decision ruling in favor of Volcano and its subsidiary Axsun Technologies Inc., and against LightLab...

February 1, 2011 – A self-anchoring aortic heart valve has received the CE mark. With the approval, the Perceval S Sutureless biological valve, by the Sorin Group, is now commercially available in...

January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the...

January 31, 2011 – The U.S. Food and Drug Administration (FDA) has approved a system for accessing and delivering diagnostic, embolic and therapeutic materials into the peripheral vasculature. The...

January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The...

January 27, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional investigational device exemption (IDE) approval to evaluate the safety and effectiveness of a cath lab robotic...

January 27, 2010 – An ergonomic, peel-away introducer sheath was launched this week to facilitate placement of electrophysiology device leads and catheters in the venous system.

January 26, 2011 - The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the...

January 25, 2011 – A microcatheter offering superior crossability, flexibility and guidewire support during coronary and peripheral catheterization procedures was released this week by Vascular...

January 25, 2011 – The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart...

January 24, 2011 – A new device for treating peripheral artery disease (PAD) is now available in Europe. W.L. Gore and Associates announced the availability of its Viabahn Endoprosthesis on a...

January 24, 2011 – The first U.S. clinical implant of a device designed to restore more natural breathing patterns in patients with central sleep apnea was made last week at The Ohio State...

Contrast-enhanced ultrasound (CEUS) can "dramatically improve" physicians' ability to detect heart disease and stratify future risk, said Thomas Porter, M.D., at the 16th European Symposium on...

January 21, 2011 – Intravascular ultrasound (IVUS) enabled physicians to more accurately assess the risk of individual blockages than the use of the current standard of angiographic imaging alone...

January 20, 2011 – European CE mark approval was granted to expand the indication of Abbott’s Xience Prime everolimus-eluting coronary stent for the treatment of critical limb ischemia (CLI) or...

The Society for Cardiovascular Angiography and Interventions (SCAI) this week published guiding principles and best practices for the development of radiation safety programs in cardiac...

Continuing to build a portfolio of transcatheter structural heart technology, Boston Scientific today signed a definitive merger agreement to acquire Atritech Inc. Atritech developed the Watchman...

January 19, 2011 – The patient support group Mended Hearts, in partnership with Daiichi Sankyo Inc. and Eli Lilly and Company, this week launched the Stent Hub – an online patient and caregiver...

January 19, 2011 – GE Healthcare and Veran announced a strategic supplier agreement this week in which GE became the exclusive distributor and reseller of Veran’s ig4 fusion imaging angiography...

January 19, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional approval to modify the CoreValve U.S. pivotal clinical trial to eliminate the medical management arm of the study...

January 18, 2011 – The first endovascular device approved for the treatment of pulmonary embolism (PE) was granted CE-mark approval this week in Europe. The Ekos EkoSonic Endovascular System was...

January 19, 2011 – The U.S. Food and Drug Administration (FDA) this week granted market clearance for Cook Medical’s Formula balloon-expandable renal stent system. The approval includes both the...

January 13, 2011 – A catheter that removes emboli and thrombi from vessels in the coronary and peripheral vasculature has received 510(k) clearance from the U.S. Food and Drug Administration. The...

January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease.

The trial will examine rates of device-...

January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a...

January 13, 2011 – A new robotic navigation system has both received the CE mark and undergone its first successful cardiac ablation procedure. The Vdrive robotic navigation system, from...

January 12, 2011 – A new, next-generation vascular closure device has been launched in the United States. The Mynx Cadence Vascular Closure Device (VCD), from AccessClosure, offers physicians...

January 12, 2011 – The Society for Cardiovascular Angiography and Interventions (SCAI) has published a paper on the future trends and developments in the cardiac catheterization laboratory and...

Two applications will help clinicians perform interventions with confidence and accuracy.

January 11, 2011 – TriReme Medical has signed an exclusive distribution and sales agreement with Century Medical for the Japanese market. Century Medical will sell TriReme’s compete line of...

January 11, 2011 – Stereotaxis has named Siemens as the non-exclusive reseller of the Odyssey Enterprise Cinema solutions. These products are designed to enhance patient care by enabling hospitals...

January 11, 2011 – A new vascular access system is available in the United States and Europe. The SmartNeedle Vascular Access System, by Vascular Solutions, consists of a hand-held monitor and one...

January 10, 2011 – European CE mark approval was announced today for the Abbott, Absorb drug-eluting bioresorbable coronary stent. It is the first bioresorbable stent to gain regulatory approval...

January 7, 2011 – A new study from The Ohio State University found that Protandim can suppress intimal hyperplasia, the over-proliferation of cells that line the walls of blood vessels. The...

January 7, 2011 – The United States Patent and Trademark Office (USPTO) has granted an additional patent expanding protection of endothelial progenitor cell (EPC) capture technology. It applies to...

January 7, 2011 – A new access device is now available in cath labs across the United States. The Arstasis One Access Device, from Arstasis, is the first commercially available alternative to the...

January 6, 2011 – Boston Scientific has completed its acquisition of transcatheter valve developer Sadra Medical.

December 5, 2010 – Additional lots lots of the AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheters are being recalled by the AngioScore Inc. The class I recall was...

January 4, 2010 – The U.S. Food and Drug Administration (FDA) has released an update of what medical devices it expects to be developed and brought to market within the next 10 years.

January 3, 2011 – Two new classes — “Advanced Computed Tomography (CT) Imaging for Technologists” and “Advanced Non-Contrast Magnetic Resonance Angiography (MRA)” — are being offered to educate...

January 3, 2011 – ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross .014-inch Over-the-wire (OTW) peripheral transcatheter angioplasty (PTA) dilatation...

January 3, 2011 – Arrow International, a division of Teleflex Medical, issued a class I recall, advising customers to immediately discontinue use of its Ultra 8 French intra-aortic balloon pump (...

December 29, 2010 - Research on reducing risks, improving medical treatment and improving lifestyle behaviors to fight the battle against heart disease and stroke are among the key scientific...

December 29, 2010 – Patient enrollment has been completed for a Phase III trial of an oral Factor Xa inhibitor. The ENGAGE AF-TIMI 48 study will investigate edoxaban, by Daiichi Sankyo, for...

December 29, 2010 – The U.S. Food and Drug Administration (FDA) has approved a stent graft system for treating abdominal aortic aneurysms (AAA). The Endurant AAA Stent Graft System, from Medtronic...

December 29, 2010 – An international trial for a self-apposing stent has begun, with 50 of the total 500 patients already enrolled. The APPOSITION III trial will look at the Stentys self-apposing...

December 29, 2010 - America is winning a battle against heart disease and stroke mortality, but is still losing the war, according to the American Heart Association.

December 27, 2010 – A case report in Circulation describes the association of stent thrombosis with lipid core plaque as detected by the LipiScan Coronary Imaging System. The LipiScan...

December 22, 2010 – The first implants of the Medtronic CoreValve transcatheter aortic valve were made this week in the pivotal U.S. clinical trial.

December 21, 2010 – A new introducer kit is now available in the United States. The VSI StraitSet Kit, from Vascular Solutions, contains a triaxial introducer comprising a 6 French, a 20 cm sheath...

December 17, 2010 – Data published in Circulation: Cardiovascular Interventions showed that a protein used with coronary stents significantly reduced two key biomarkers of cardiac...

December 17, 2010 – Meta analysis data delivered at the Innovations in Interventional Cardiology 2010 meeting demonstrated the low adverse cardiac events of a coronary stent merged with an embolic...

December 17, 2010 - The U.S. Food and Drug Administration (FDA) has requested additional analyses of the trial data in its review of the new antiplatelet agent ticagrelor (Brilinta).

December 17, 2010 – The first truly detachable hydrogel polymer embolic device is now available nationwide. The AZUR Peripheral HydroCoil 35 platinum coil embolization system, from Terumo...

December 16, 2010 – A system designed to improve acute coronary syndrome (ACS) revascularization following percutaneous coronary intervention (PCI) has received CE Mark.

December 10, 2010 – European CE mark approval has been granted so the Medtronic CoreValve transcatheter aortic valve replacement system can be delivered through the subclavian artery, located...

December 7, 2010 - In an effort to improve the diagnosis and treatment of peripheral artery disease (PAD), the American College of Cardiology and American Heart Association issued the first-ever...

December 7, 2010 – A study comparing a transcatheter ventricular assist device (VAD) to intra-aortic balloon pumps (IABP) has been completed after interim analysis determined the primary endpoint...

December 7, 2010 – A new bioresorbable stent scaffold can be overinflated by more than 25 percent without cracking or crazing. New data from Arterial Remodeling Technologies (ART) show that its...

December 6, 2010 - A European court has struck a blow to Boston Scientific's alleged patent infringement case against OrbusNeich. The case is viewed by OrbusNeich as an unsuccessful retaliatory...

December 6, 2010 – Cordis Corp. has entered into a distribution agreement with Ostial Solutions for the worldwide distribution of the Ostial Pro Stent Positioning System.