FzioMed, a US-based privately held medical device company, has included its Dynavisc on the Australian Register of Therapeutic Goods (ARTG). Dynavisc is an absorbable, viscoelastic gel that is applied to tendons and peripheral nerves to ...
Tags: FzioMed, medical device
Medtronic has enrolled the first patients in a blinded, controlled, multicenter, parallel arm SubQStim II study of its peripheral nerve stimulation (PNS). Delivered to patients using the company's neurostimulation system, PNS is designed ...
US based medical technology company Medtronic has introduced CardioGuide implant system in the US and Canada. The real-time navigation system is designed for determining the real-time location to place left-ventricular (LV) electrode lead ...
The European Union (EU) has granted CE mark certification to Medtronic's Sentrant Introducer Sheath for the endovascular repair of aortic aneurysms. Designed for use with the company's Endurant II AAA and Valiant Captivia Stent Graft ...
Tags: aortic aneurysms, Medtronic, Sentrant Introducer Sheath
Aptus Endosystems has received CE mark approval from the European Union for its thoracic-length Heli-FX system for thoracic aortic aneurysms (TAA) treatment. Featuring a longer delivery device with additional tip configurations, the ...
Tags: Heli-FX System, Medicine, Medical Device
US-based medical technology company Medtronic has secured US marketing rights for its Affinity Fusion oxygenation system following the regulatory approval from the US Food and Drug Administration (FDA). The CE-marked system, which serves ...
Tags: FDA, Fusion Oxygenation System
Medtronic has submitted its investigational device exemption (IDE) application to the FDA to initiate a study of its Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure ...
Medtronic has obtained CE mark certification from the European Union for its Attain Performa portfolio of quadripolar leads. The quadripolar leads are compatible with the company's Viva/Brava Quad cardiac resynchronization therapy ...
Tags: Medtronic, CE mark certification, Attain Performa portfolio
Medtronic has gained CE mark approval for its Engager transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, from the European Union (EU). The new TAVI system, which is inserted in the apex (the lower, ...
Tags: Medtronic, transcatheter aortic valve implantation, TAVI
Medtronic has obtained regulatory approval from the US Food and Drug Administration (FDA) to conduct an early feasibility study on its Native Outflow Tract transcatheter pulmonary valve (TPV), designed for the treatment of patients with ...
Tags: Medtronic, Native Outflow TPV, Medicine
Medtronic has gained US marketing rights for new sizes of its Resolute Integrity drug-eluting stent, following the regulatory approval from the Food and Drug Administration (FDA). Available in 34mm, 38mm lengths and 3.0mm, 3.5mm and 4.0mm ...
The US Food and Drug Administration (FDA) has granted approval to Medtronic's AIRvance Bone Screw System. The approval allows surgeons to perform a hyoid suspension procedure independently or in combination with other procedures including ...
Medtronic has launched new MR-Conditional pacing system for use with MRI scanners in the US, following the approval from the US Food and Drug Administration (FDA). The Advisa DR MRI SureScan pacing system, which includes an Advisa MRI ...
Medtronic has commenced prospective, open-label, parallel-group PROMISE trial of its neurostimulation therapy device for treating patients with chronic low back pain associated with failed back surgery syndrome (FBSS). The spinal cord ...
Medtronic has received CE mark approval for its Complete SE vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs. The ...