Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.
Neuro
AANS sees Debut of DePuy’s ANSPACH® EG1 High Speed Drill System
DePuy Synthes Power Tools has launched its “Next Generation”, 30% more powerful electric drill system for neurosurgery, otology and spinal procedures.
Medtronic Buys into Turkish Distribution
Medtronic has signalled its intent to get to the sharp end in a significant market, by acquiring a majority of the shares of Biostar, which will assume the distribution of Medtronic products in Turkey. Former distributor Medicall Biomedikal A.S. will assume management responsibilities.
Mazor Robotics to Launch New Renaissance® Brain Module at AANS
This weekend sees the American Association of Neurological Surgeons (AANS) annual meeting, starting April 7, 2014. Mazor Robotics is using the occasion to debut and officially launch the new Renaissance Guidance System brain module, which it says is FDA-cleared for both spine and brain surgery.
Australia Approves NeuroSigma’s Monarch™ eTNS™ System for Drug-Resistant Epilepsy
NeuroSigma gained the European CE mark for its Trigeminal Nerve stimulation system in 2012. Now the Australian TGA has given the device its approval for use in adjunctive treatment of drug-resistant epilepsy.
Cook Medical Says Biodesign® Dural Substitute is Ideal CSF Leak Solution
CSF Leakage at the skull base is an occupational hazard for neurosurgeon and otolaryngologist alike. Now Cook Medical has introduced a naturally sourced dural substitute that it claims hits the spot in resolving the troublesome condition.
FDA Clears Device to Avoid Nerve Injury Caused By “Positioning Effect”
Surgical patients can suffer nerve impairment due to so-called “positioning effect”. Now SafeOp Surgical’s newly FDA cleared system uses neurological monitoring to flag up potential peripheral nerve damage.
Stryker Launches TREVO® XP PROVUE Clot Retrieval System
Stryker is trumpeting the global launch of its new Trevo® XP ProVue Retriever, expanding its line of stent-based clot retrieval devices with additional shapes and sizes.
CE Mark for AspireSR™ Generator Means Automatic VNS Therapy® when Seizure Predicted
Cyberonics, Inc. has gained CE Mark approval for its AspireSR generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.
Medtronic’s Earnings Stung by Renal Denervation Write-Down
Some solid revenue growth for Medtronic, compared with the same quarter a year ago, were somewhat spoiled by a $200 million write down following the poor outcome from its much vaunted Symplicity HTN-3 Study.
CE Mark and First Case for Reverse Medical’s UNO™ Neurovascular Embolization System for Intracranial Use
Reverse Medical Corporation, a frequent visitor to our pages, has announced CE Mark and the initial clinical use of the UNO™ Neurovascular Embolization System for intracranial use in obstructing blood flow in the Neurovasculature.
FDA filing for eNeura’s SpringTMS® Migraine Treatment
eNeura Inc., a privately held medical technology company, has announced the filing of a 510(k) with the U.S. FDA for the SpringTMS® transcranial magnetic stimulation (TMS) device, a progression from its already approved CerenaTMS solution for migraine treatment.
It’s Win-Win: Confluent Suit Fits Integra Better than it did Covidien
Covidien has completed the sale of its Confluent Surgical product line to Integra LifeSciences Corporation for approximately $235 million in cash and is seemingly pleased to be rid of it. Integra will benefit from a highly complementary product.
Stryker to Sell Neurologica’s CT Scanner in Defined Specialties
Stryker Corporation and NeuroLogica have entered into an exclusive partnership agreement under which Stryker will promote and sell NeuroLogica’s BodyTom portable full body computed tomography (CT) scanner for the specialties of neurosurgery, spine surgery, orthopaedic surgery, and trauma surgery in conjunction with the Stryker NAV3i™ Surgical Navigation Platform.
Medtronic Acquires TYRX, Inc., with its Antibacterial Device Envelopes
We’ve covered TYRX’s clever antibacterial, FDA cleared, device envelopes before, mainly because it’s an interesting concept. Medtronic thinks so… it likes it so much it’s bought the company.
CE Mark and Clinical Use of Reverse Medical® BARREL® Device for Reconstruction of Intracranial Bifurcation Aneurysms
Reverse Medical® Corporation has announced CE Mark approval for its BARREL® Vascular Reconstruction Device (VRD) and the first European clinical case. The BARREL® Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.