FDA Approves IDE for Pulsar Vascular’s PulseRider Aneurysm Neck Reconstruction Device

June 10, 2014—Pulsar Vascular announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for the PulseRider, the company’s minimally invasive aneurysm neck reconstruction device. The IDE allows Pulsar Vascular to begin a multicenter clinical trial in support of a humanitarian device exemption to evaluate the PulseRider for United States approval for wide-neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus.

Baxano Surgical Receives 510(k) Clearance for the Avance MIS Pedicle Screw System

RALEIGH, N.C., April 10, 2014 -- (Healthcare Sales & Marketing Network) -- Baxano Surgical, Inc. (BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug Administration 510(k) clearance (k133743) of its Avance(TM) MIS Pedicle Screw System, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. The innovative design of Avance provides a quick and easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The Avance system will be in limited market release in the second and third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.

Medicrea Announces European Launch of UNiD, the World´s First Patient-Specific Spinal Rod

LYON, France--(Healthcare Sales & Marketing Network)--The MEDICREA group (ALMED.PA) (Alternext Paris: FR0004178572-ALMED), a company that specializes in the development of innovative surgical technologies for the treatment of spinal pathologies, today announced the European launch of the UNiD, the world´s first patient-specific spinal osteosynthesis rod system.

Reverse Medical(R) Corporation Announces FDA IDE Approval for the BARREL(R) Vascular Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms

IRVINE, Calif.--(Healthcare Sales & Marketing Network)--Reverse Medical® Corporation today announced FDA IDE approval for clinical investigation of their BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.

Neurosurgery journal published study reinforces value of high-field iMRI

VISIUS intraoperative MRI significantly enhances amount of complete resection in brain tumors and leads to better patient outcomes.

RTI Surgical(TM) Announces Launch of Streamline(R) OCT System

ALACHUA, Fla.--(Healthcare Sales & Marketing Network)--RTI Surgical Inc. (RTI) (RTIX), a leading global surgical implant company, announced today the full market launch of the Streamline® OCT System. The system is designed to promote fusion of the occipto-cervico-thoracic spine (or occiput-T3). RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in March 2014.

GS Medical USA Announces FDA Clearance and Launch of AnyPlus(R) T/PLIF Cage

FDA Approves Inspire(R) Upper Airway Stimulation (UAS) Therapy for Obstructive Sleep Apnea

MINNEAPOLIS, May 1, 2014 -- (Healthcare Sales & Marketing Network) -- Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP). Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnea, that provides an alternative treatment that is proven, convenient and easy to use.

Long Term Follow Up Data On WEB Aneurysm Embolization System Demonstrate High Rate Of Stable Occlusion In Difficult To Treat Aneurysms

Sequent Medical, Inc. announced today the presentation of long-term results from a retrospective study of the WEB™ Aneurysm Embolization System at the World Federation of Interventional Neuroradiology (WFITN) Congress.

Data Support Sequent Medical’s Web Aneurysm Embolization System

Sequent Medical, Inc. (Aliso Viejo, CA) announced the presentation of long-term results from a retrospective study of the company’s Web aneurysm embolization system at the World Federation of Interventional Neuroradiology Congress in Buenos Aires, Argentina. The data were presented by Professor Laurent Pierot, MD, who is Head of the Department of Radiology at Maison Blanche Hospital in Reims, France.

Venous narrowing not linked to MS

There is no association between MS (multiple sclerosis) and venous narrowing, specifically the narrowing of the veins from the brain to the heart (extracranial veins), researchers reported in The Lancet.

United States Pivotal Trial Begins of MicroVention’s FRED Stent for Cerebral Aneurysm Flow Diversion

MicroVention, Inc. (Tustin, CA), a wholly owned subsidiary of Terumo Corporation (Tokyo, Japan), announced initiation of enrollment in a multicenter, prospective, pivotal clinical trial in the United States to demonstrate the safety and efficacy of the company’s flow diversion system called FRED (flow-redirection endoluminal device), for treating intracranial aneurysms. The FRED system has received CE Mark approval for use in Europe and several other international markets.

Meta-Analysis Conducted of Endovascular Treatment of Intracranial Aneurysms in the Elderly

In Stroke, Carmelo L. Sturiale, MD, et al published findings from a systemic review and meta-analysis of endovascular treatment of intracranial aneurysms in elderly patients (2013;44:1897–1902). The investigators were from the Mayo Clinic in Rochester, Minnesota, and led by Giuseppe Lanzino, MD. They noted in the background of the study that the use of endovascular coiling for treating ruptured and unruptured intracranial aneurysms in the elderly is increasing, so they performed a meta-analysis of the literature examining clinical and angiographic outcomes.

Zoll Medical Acquires Assets of CoAxia

Zoll Medical Corporation (Chelmsford, MA) announced that it has purchased the assets of CoAxia, Inc. (Maple Grove, MN). Zoll Medical Corporation, which is a manufacturer of medical devices and related software solutions, is one of a diversified group of companies of the Asahi Kasei Corporation (Tokyo, Japan). CoAxia is an early revenue-stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm after subarachnoid hemorrhage.

Enrollment Begins in SCAFFOLD Study for Gore Carotid Stent

Gore & Associates (Flagstaff, AZ) announced commencement of enrollment in SCAFFOLD, the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy.