The FDA approved two cardiac ablation catheters made by St. Jude Medical Inc. (NYSE:STJ).
The devices are designed to treat cardiac arrhythmias through the targeted scaring of heart tissue to block abnormal electrical signals that would contribute to irregular heart beats.
The new Safire BLU and Therapy Cool Path catheters are bi-directional, with a tip that turns 180 degrees, and irrigated, to help reduce the risks associated with the high heat involved with ablation, according to the St. Paul, Minn.-based company.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Medtronic wins FDA approval for bowel control therapy with its InterStim
Medtronic, Inc. (NYSE:MDT) announced FDA approval of InterStim Therapy for bowel control. InterStim Therapy, previously available to treat the symptoms of overactive bladder and non-obstructive urinary retention, is now also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
Read more - CytoSorbents wins CE Mark for the CytoSorb
CytoSorbents Corporation (OTC:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, received CE Mark (Conformité Européene) approval for its flagship product, CytoSorb, as an extracorporeal cytokine filter in situations where excessive cytokine levels exist.
Read more - AngioScore launches new AngioSculpt devices for peripheral artery disease
AngioScore, Inc., a developer of angioplasty catheters for use in the treatment of cardiovascular disease, launched a new, longer AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD). The new devices have received FDA 510(k) clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device won FDA approval as an alternate supplier for the nitinol scoring element in September 2010.
Read more - Scientia Vascular’s PLATO microcatheters granted CE mark
Scientia Vascular’s PLATOTM Microcath received CE Mark approval, for European neuro, cardio and peripheral endovascular applications. The company is a developer of products that are optimized for endovascular access and therapies.
Read more - CardioNexus’ CardioHealth station cleared by FDA
CardioNexus Corp.’s Panasonic CardioHealth Station just received clearance from the FDA. The device is an automated and portable cardiovascular imaging device which aims to complement traditional blood pressure and cholesterol measurement in physicians’ offices and to help detect the hidden risk of heart attack and stroke. CardioNexus is an affiliated company of Panasonic Healthcare Co. Ltd.
Read more - NeuroLogica wins FDA 510(k) clearance for BodyTom
NeuroLogica Corporation announced the receipt of 510(k) clearance from the FDA for the world’s first portable, full body, multi-slice CT scanner, the BodyTom. The BodyTom is the newest offering in NeuroLogica’s portable computed tomography imaging line. BodyTom™ is a completely portable, full body, 32 slice CT that boasts an impressive 85cm gantry and 60cm field of view (FOV).
Read more - Abbott wins CE Mark for Hepatitis B sequencing test
Abbott Laboratoies (NYSE:ABT) unit Abbott Molecular announced that it has received CE Mark approval to market the Abbott HBV Sequencing test in the European Union. This molecular diagnostic test, developed to identify genomic sequences of the hepatitis B virus (HBV) and help physicians monitor HBV infections, guide treatment decisions, and predict or discover drug resistance, is the first DNA sequencing assay developed and introduced by Abbott Molecular.
Read more - Abbott launches MitraClip in Australia
Abbott announced the launch of the company’s catheter-based MitraClip system for the treatment of mitral regurgitation (MR) in Australia. The MitraClip device, which has received Therapeutic Goods Administration (TGA) approval, offers a new treatment option for patients suffering from MR, a debilitating heart valve condition.
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