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.

Boston Scientific Corp. has received FDA approval for two implantable defibrillators, CONFIENT and LIVIAN, and an upgraded LATITUDE Patient Management System. The CONFIENT ICD (implantable cardioverter defibrillator) helps protect patients at risk of sudden cardiac death. The LIVIAN CRT-D (cardiac resynchronization therapy defibrillator) provides cardiac resynchronization and defibrillation therapies in a single device. The upgraded Latitude Patient Management System enables physicians to remotely monitor patients.

The delay in Trasylol’s withdrawal from the U.S. market may have resulted in the death of 22,000 patients, according to a medical researcher. Trasylol, a blockbuster drug for Bayer that had been approved for stemming bleeding during open heart surgery, had been withdrawn in November at the request of the FDA. According to Dr. Dennis Mangano, who conducted the study that linked the drug to kidney failure, Bayer had known about the dangers of the drug, but had refrained from communicating the same during an FDA advisory panel meeting in September 2006.

The warning image pictured here now appears when you visit the Trasylol Website.

Patients are at a higher risk of a cardiovascular incident and maybe even death during the first three months after they stop taking Sanofi-Aventis’ Plavix, according to a new research published in the Journal of the American Medical Association. Patients who have suffered a heart attack or have received a stent are put on Plavix (clopidogrel), which prevents the formation of blood clots. Dr. P Michael Ho, a lead author of the report, said, “It was almost a twofold increased risk in that initial period compared to later follow-up periods.”