“I’ve been a surgeon since 1960 and this technology is one of the most significant operating room advances I’ve seen in decades”
Approval/Clearance
First U.S. Patients for Biotronik’s Newly Approved Itrevia HF-T QP CRT-D Device
Device incorporates latest defibrillator technology, closed loop stimulation and compatibility with a quadripolar lead
CE Mark for SinuSys™ Vent-Os® Sinus Dilation System for Treatment of Frontal and Sphenoid Sinusitis
Two new devices will expand portfolio of low-pressure, self-expanding dilation devices to treat frontal and sphenoid sinusitis, in addition to maxillary disease.
Ventilation System Clearance for Breathe Technologies
Breathe Technologies has gained FDA 510(k) clearance for its Life2000 Ventilation System for people needing mechanical ventilation
CE Mark for St. Jude’s “Industry First” Neuromodulation Trial System
St. Jude Medical, Inc., has gained CE Mark approval and announced the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system leveraging Apple™ iPod touch™ and iPad mini™ technology.
Taking the Guesswork out of Epidural’s: FDA Clears Ultrasound Guidance System
Rivanna Medical’s Accuro™ system is the first ultrasound guidance system to provide 3D navigation to an anatomical target
FDA Clears Penumbra’s ACE64 Thrombectomy System for Stroke Treatment
Latest mechanical thrombectomy device delivers higher revascularization rates, reduced procedure time and cost
CE Mark for Abbott’s New Absorb GT1™ Stent System
New generation of Abbott’s absorbable stent line features improved access and deliverability
FDA (510k) Clearance for Magstim’s rTMS (repetitive Transcranial Magnetic Stimulation) Therapy System
Pioneering device manufacturer cleared for U.S. launch of its Rapid2 Therapy System for treatment of drug resistant Major Depressive Disorder
CE Mark for Second Generation Endostim Neurostimulation Device for GERD
Endostim’s thinner, smaller new lower esophageal sphincter stimulating device promises an improved patient experience
CE Mark for Arterial Remodeling Technologies’ Pure Bioresorbable Scaffold
Arterial Remodeling Technologies has gained CE Mark approval for its next generation drug free, pure bioresorbable scaffold used to treat coronary artery disease
CE Mark of Perivascular Alcohol Denervation System for Hypertension
CE Mark of the Ablative Solutions Peregrine System™ Infusion Catheter signals continued interest in renal denervation therapy
EU Nod for St. Jude’s ICD MRI-Compatibility Claim
MRI-conditionality is rapidly becoming industry standard, at least in St. Jude’s range, as more ICD products are approved to make this claim in Europe
Australian Approval for GORE® EXCLUDER Iliac Branch Endoprosthesis
Gore’s newly approved device builds on its Excluder family of AAA treatment devices and is the first dedicated for use in the common iliac artery
FDA Approval and CE Mark for Medtronic’s Arctic Front Advance® ST Cryoballoon
Based on clinician feedback Medtronic’s third generation cryoballoon nudges ablative treatment of atrial fibrillation along
Another Spinal Cord Stimulation System Gets Pain Indication
Nevro Corporation has received approval from the U.S. FDA for its Senza spinal cord stimulation (SCS) system for the treatment of chronic pain.