A new platinum-based stent, designed by Boston Scientific, has received its CE Mark and will now be available in the relevant countries. The PROMUS Element Everolimus-Eluting Coronary Stent System was granted approval by the Dutch notified body KEMA Quality BV. In addition to featuring a platinum chromium alloy designed specifically for coronary stenting, the system has an innovative stent structure and an impressive catheter delivery mechanism.

FlowCardia, Inc has launched the FlowMate Injector, which dramatically simplifies central lumen crossing of CTOs using the CROSSER CTO Recanalization Catheter. FlowMate provides unparalleled convenience by granting full control of the procedure to a physician via a single foot pedal, which initiates FlowMate’s precise saline delivery as well as the Generator which activates the CROSSER Catheter. Fixed injector settings are integrated into the FlowMate adding even greater convenience and ease of use.

Sorin Group has announced the Japanese approval and the market release of ISOLINETM1, its latest generation of defibrillation leads. Leads are insulated wires inserted through the vein as part of an implantable cardioverter defibrillator (ICD) or a pacemaker system. Connecting the device to the heart, the leads carry high voltage and electrical impulses from the implanted device to the heart when needed by the patient. ISOLINETM defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes.

The U.S. Food and Drug Administration has given 510(k) clearance to Cardium Therapeutics’ operating unit InnerCool Therapies, Inc. for the commercialization of its RapidBlue(TM) System, a system to regulate body temperature. The closed loop catheter-based system of the device modulates body temperature by circulating saline within the catheter’s interior. Underwriters Laboratories found that the system met all the medical electrical safety standards including UL 471 Standard for commercial refrigerators, the first global certification for an endovascular thermal regulating device.

The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

The U.S. Food and Drug Administration has given the approval in the form of a Humanitarian Device Exemption (HDE) for Levitronix’s CentriMag Right Ventricular Assist System providing patients in critical condition with temporary aid for the right ventricle of their heart. The heart pump supports the pumping action of a heart not functioning properly. The indication facilitates the development of the device for treatment of the severe right-side heart failure, which although uncommon, can lead to death. The device was found to be safe for use.

TyRx, Inc. has launched the AIGISRX(TM) ICD, an anti-bacterial envelope designed to stabilize the implanted device and which also contains anti-microbial agents that protect against surgical site infections (SSI) associated with implantable cardioverter defibrillators (ICDs). Doctors insert the ICD into the AIGISRX during a CRMD implantation procedure and position the device within the pocket created by surgery. On being implanted, the anti-bacterial envelope provides an add-on to general antibiotic treatment. It elutes the anti-microbial agents rifampin and minocycline, thereby stabilizing the implanted ICD.

Actavis Group’s U.S. division, Actavis Totowa LLC, has recalled all lots of heart failure treatment Digitek (digoxin tablets). The company announced the Class I nationwide recall for Digitek after the possible commercial release of tablets with twice the approved level of the active ingredient, posing a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

 St. Jude Medical Inc. has launched the TigerWire steerable guidewire in the U.S. A guidewire is used by physicians to move a catheter through the arteries. It enables doctors to diagnose the severity of disease and deliver treatments such as stents to open blockages and restore blood flow.

B. Braun has launched its drug eluting balloon (DEB) catheter in Kuala Lumpur. The DEB catheter, SeQuent™ Please, has the potential of becoming an alternative to the use of drug eluting stents (DES) for selected heart patients, which has been the first line treatment for coronary artery disease (CAD). A DES is a small wire mesh that is coated with a drug and implanted to widen the arteries to allow blood to flow more freely.