The Modular PMA means companies can submit their data sequentially to the FDA en route to ultimate approval. Sapheon has reached stage 2 with its Venaseal varicose vein treatment system.
Products
FDA Clears Smiths Medical CADD®-Solis Pain Pump
Smiths Medical says its newly cleared CADD®-Solis pain management system combines Patient controlled and Programmed Intermittent Bolus deliveries for labor analgesia and post-operative pain management
EndoVascular Aneurysm Sealing System Study OK’d
Endologix, Inc., has received Investigational Device Exemption (“IDE”) approval from the US FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of its Nellix® EndoVascular Aneurysm Sealing System (“EVAS”) for the endovascular repair of infrarenal abdominal aortic aneurysms.
Green Light for InVivo’s Spinal Cord Repair Device Study
It’s all happening at InVivo Therapeutics. In a flurry of news releases the company has appointed a new CEO, gained conditional approval to commence its US trial and gone ahead and satisfied the conditions with a series of responses to the FDA’s outstanding issues. The study will commence with first patients in early March.
Device Alert for Upside Down Vena Cava Filter
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.
CE Mark Brings Baxter’s VIVIA High Dose Hemodialysis System to Europe
Baxter International Inc. has gained CE mark approval for its VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy.
Axios Pancreatic Stent Cleared Under FDA’s De Novo Pathway
The U.S. FDA has allowed Xlumena’s AXIOS Stent onto the market under its de novo pathway. AXIOS is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
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.
FDA Clears AMS RetroArc™ Retropubic Female Stress Urinary Incontinence Sling
The FDA has granted 510(k) Clearance of the American Medical Systems® RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI). The company says its system incorporates enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.
U.S. Launch of Nuvasive’s ALIF ACR™
MIS spine device company NuVasive®, Inc. has announced the U.S. launch of its ALIF ACR™ (Anterior Lumbar Interbody Fusion – Anterior Column Realignment) system.
CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems
Boston Scientific has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems and seen first implantations in Italy.
FDA Clears First Device to Relieve Migraine Headache Pain
The U.S. FDA has cleared the eNeura Therapeutics’ Cerena Transcranial Magnetic Stimulator (TMS), making it the first device to relieve pain caused by migraine headaches that are preceded by an aura.
U.S. Launch for DePuy Synthes Trauma Modular Radial Head Prosthesis System
DePuy Synthes Trauma has announced the U.S. launch of a new Radial Head Prosthesis System for primary and revision joint replacement of the radial head to restore joint function.
CE Mark for 25mm Portico Transcatheter Aortic Heart Valve from St.Jude Medical
St. Jude Medical, Inc. has gained CE mark approval for a 25 mm iteration of its Portico™ Transcatheter Aortic Heart Valve Implantation System, extending the applicability of the device to more patients for whom transcatheter aortic valve replacement (TAVR) is indicated.
Tissue Regenix Aiming High with US Distribution Plans for DermaPure™ Chronic Wound Therapy
UK wound healing expert company Tissue Regenix is planning to launch its biological scaffold product, DermaPure™, in early 2014 and is putting in place an extensive distribution network to make sure it gains appropriate coverage.
FDA Clears Ethicon-Endo’s New Harmonic Focus®+ Shears With Adaptive Tissue Technology
Newly cleared Harmonic Focus® + Shears with so-called Adaptive Tissue Technology promise accurate resection with consequent enhanced speed and surgical precision.