Svelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

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Biosense Webster, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the CartoXPress™ Software Module and the Lasso® NAV Circular Mapping Catheter for use with the Carto® XP Mapping System. These two new innovations provide electrophysiologists who do not have access to the Carto® 3 System, the company’s latest revolutionary 3D Mapping technology, with increased speed and efficiency in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms.

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St. Jude Medical, Inc. has announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy(TM) Cool Path(TM) Ablation Catheter. This marks the company’s first entry into the irrigated catheter ablation market in Japan. The Therapy Cool Path Ablation Catheter is a thin, flexible tube that delivers radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars.

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Boston Scientific Corporation has announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included an indication for the treatment of diabetic patients.

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Abbott announced the European approval and launch of its TREK(TM) Coronary Dilatation Catheter for the treatment of coronary artery disease. The TREK system represents a new approach to balloon catheter design, and provides physicians with a high-performing option for treating challenging lesions and difficult-to-reach blockages. Abbott received CE Mark for the TREK system earlier this year. The TREK family is a completely re-engineered line of balloon catheters, incorporating many advanced design and technology changes.

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The Food and Drug Administration has approved Medtronic Inc’s heart valve that can be implanted without open-heart surgery. Known as the Melody transcatheter pulmonary valve, the device is designed to be implanted through a small catheter inserted into the patient’s body. It replaces the pulmonary valve in patients born with a heart defect. It is the first heart valve approved for sale in the US that can be implanted without open-heart surgery.

Cardiovascular Systems, Inc. has announced the first patient enrollment in its prospective, randomized CALCIUM 360 degree clinical trial, part of the company’s 360 degree Clinical Series. The CALCIUM 360 degree study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360^® PAD System, a minimally invasive catheter for treating PAD anywhere in the leg.

Onset Medical Corporation has announced that it has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter. These catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Another clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treating aortic aneurysms.

Vascular Solutions, Inc. has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the GuideLiner(TM) catheter. The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line.

The FDA has sent letters to physicians declaring a Class 1 recall of the Sutureless Connector intrathecal catheter made by Medtronic Inc. The device might be incorrectly labeled as compatible with the IsoMed Pump Model 8472, a drug pump Medtronic discontinued last year as part of what it calls a “planned product phase-out.” The catheter models 8709SC, 8731SC, 8578, and 8596SC are affected by the recall. Even though the catheter appears to fit the pump, the connection is not secure, which can cause drugs or cerebrospinal fluid to leak out, resulting in drug overdose, tissue damage and so-called spinal headaches.