The FDA granted Medtronic Inc. (NYSE:MDT) approval for its Protecta series of implantable cardioverter-defibrillators, which had been delayed by regulatory snafus.
The Fridley, Minn.-based company’s resolution of a Nov. 2009 warning letter enabled the company to receive approval from the FDA for the Protecta ICD portfolio.
The Protecta devices had been under an “approvable letter,” meaning the FDA expected to approve the products once the company resolved manufacturing issues at its Mounds View, Minn., facility. The company fixed the problems in early March. Medtronic had already launched the Protecta devices in Europe last June after receiving CE Mark approval in March 2010.
Medtronic said the new defibrillators include the company’s SmartShock technology, which is designed to better recognize cardiac arrhythmias and deliver therapeutic shocks only when appropriate. Most ICD shocks are necessary, but studies estimate that up to 20 percent of patients with the implantable devices may experience unneeded shocks in response to benign arrhythmias or electrical noise, according to Medtronic.
MDT shares were trading up about 1.2 percent to $38.83 by the late-afternoon.
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.
- Artelon CMC Soft wins CE Mark approval
In collaboration with Small Bone Innovations (SBi), Artimplant has developed a new product in the Artelon Spacer range with a similar user-friendly textile design to Artelon Tissue Reinforcement (ATR). The product, Artelon CMC Soft, has been granted CE-approval by the certification body Lloyd’s and has thus been granted clearance for marketing in Europe.
- Pathwork lab awarded accreditation from College of American Pathologists
Pathwork Diagnostics Inc. announced that its laboratory has been awarded accreditation by the College of American Pathologists (CAP). The company’s gene expression-based Pathwork Tissue of Origin Test, offered by the Pathwork Diagnostics Laboratory, is designed to help identify the origin of metastatic and poorly differentiated tumors and increases pathologists’ and oncologists’ confidence in the cancer diagnosis.
- Cook wins 510(k) clearance for Cantata microcatheter
Cook Medical launched its Cantata superselective microcatheter at the Society of Interventional Radiology’s 36th Annual Scientific Meeting. The Cantata is designed to offer a combination of support and torqueability to help interventional radiologists navigate tortuous anatomies, while minimizing trauma with distal softness and microwire tracking. It won approval in December 2010.
- BD wins FDA clearance for automated assays for HSV1 and HSV2
BD Diagnostics, a segment Becton, Dickinson & Co (NYSE:BDX), announced today that it received FDA 510(k) clearance for the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in clinician-collected external anogenital specimens. The new BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) run on the BD Viper System with XTR Technology, which uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA.