Could renal denervation’s effect really be all placebo? That is almost impossible to believe. But something’s afoot and investigators and commentators are already speculating about what that might be.
Vascular
Second Module of VenaSeal® Sapheon Closure System PMA Submitted
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.
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.
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.
NICE Says E-vita open plus Stent Graft is Good News for Patients as well as NHS
The UK’s NICE Healthcare guidance and standards body, has published positive final medical technology guidance on the use of vascular device company Jotec’s E-vita open plus endoluminal stent graft device in the treatment of complex aneurysms and dissections of the thoracic aorta. By avoiding a second procedure the system removes risk and saves money.
First Patients Randomized in SYMPLICITY HTN-4 U.S. Study of Renal Denervation in Moderate Uncontrolled Hypertension
Medtronic, Inc., has kicked off its SYMPLICITY HTN-4 study with the news that the first patients have been randomized. The study, which started enrolling in November 2013 will evaluate the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension
Gore® Sees Viabahn® FDA Approval Extended to Include Synthetic AV Access Grafts
W. L. Gore & Associates has seen the FDA extend its indication for the GORE® VIABAHN® Endoprosthesis to include treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic AV access grafts.
New FDA Approval Means Larger Target Vessels for Reverse Medical’s Peripheral Vascular Embolizer
Reverse Medical® Corporation has gained FDA 510(k) clearance to market its MVP®-5 Micro Vascular Plug system for peripheral vessel embolization, together with news of the first US clinical case.
Bard’s Lutonix Could Be First Drug Coated Balloon to US Market
C.R. Bard has announced the submission of the final module to support FDA approval for the Lutonix® Drug-Coated PTA Dilatation Balloon/Catheter. This could put it at the front of the queue of companies hoping for a first peripheral drug coated balloon approval.
US and EU Nods for Boston Scientific’s Direxion™ Torqueable Microcatheter
Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.
Veniti(TM) Hopes Newly CE Marked Vici(TM) Venous Stent Will Conquer Venous Obstruction
Veniti™, Inc., has received approval to CE Mark the Veniti Vici™ Venous Stent, specifically designed for the treatment of venous obstruction. In addition, the company received CE Mark approval for their varicose vein ablation product, the Veniti Veni™ RF Plus Ablation System.
CE Marking Means Gore Has Endovascular Treatment Option for Iliac Artery Aneurysms
W. L. Gore & Associates has gained CE Mark approval for its GORE EXCLUDER Iliac Branch Endoprosthesis. The company says Excluder is the first complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms or aorto-iliac aneurysms.
18-month Average 24 mmHg BP Reduction Reported with St.Jude EnligHTN™ Renal Denervation System
Data presented at the TCT2013 symposium indicates that patients with drug-resistant hypertension treated with the EnligHTN™ Multi-Electrode Renal Denervation System averaged a 24 mmHg reduction in systolic blood pressure as measured in an office setting.
CE Mark for AngioDynamics’ AngioVac
MIS device company, AngioDynamics has gained CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.
Study Results Support AtheroMed’s Phoenix Peripheral Artery Disease Atherectomy System
Vascular device specialist AtheroMed, Inc., says its Endovascular Atherectomy Safety and Effectiveness (EASE) study demonstrates the safety and effectiveness of the Phoenix Atherectomy System in treating PAD. Results were presented at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas in early October 2013.
Deployment Problems Lead to FDA Recall for Bard’s LifeStent Solo Vascular Stent
The FDA has issued a Class I recall notice on certain product codes and lot numbers of Bard’s LifeStent Solo Vascular Stent, manufactured between November 2011 and June 2012. The reason for the recall is a potential failure to deploy the stent, which would have potentially serious adverse health consequences