The news that FDA’s MAUDE database of adverse events has reported an “externalisation” of St.Jude’s new and improved ICD lead is bad timing and bad news for the company.
Regulatory
Panel Must Consider Study Bias, Missing Data And Unanswered Questions Before FDA Extends Sapien Indications
FDA’s executive summary of the state-of-play going into tomorrow’s circulatory devices panel meeting is exhaustive, thorough and actually pretty impressive. Yet again though it raises the question of when enough data is enough, because no doubt Edwards Lifesciences thinks its study already looks under every rock.
ALL Anaesthetic Machines From ALL Manufacturers Targeted by UK MHRA Medical Device Alert:
UK competent authority the MHRA has taken the unusual step of using its medical device alert procedures to remind anaethestists and support staff that their machines and practices need to pass muster if they are to avoid serious patient incidents.
FDA Says Edwards Can Start Trial Of CE Marked Valve Technology
Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.
FDA 510(k) Clearance For Magellan™ Peripheral Vascular Robotic System
Hansen Medical, Inc. has announced that it has received FDA 510(k) clearance for its Magellan™ Robotic System, opening the door for transformation of vascular interventions.
CE Mark For NinePoint Medical’s NvisionVLE™ Imaging System
NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, has announced that it has gained CE mark approval for the NvisionVLE™ Imaging System.
FDA Approval and First US Surgeries For Medicrea’s LigaPASS™ Spinal Fixation System
Medicrea’s LigaPASS™ system enables spinal fixation in cases where pedicle fixation is complex or compromised. Now the product has gained FDA approval and seen its first use in US patients.
FDA Approves Longer Lengths Of PROMUS Element Plus Stent
Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths (32mm and 38mm) of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, opening the door for the treatment of longer lesions.
Outcome Data Drives S&N’s Metal Cup Recall
Smith & Nephew is withdrawing a component of one of its all-metal artificial hip systems following a higher than normal level of patient problems with the device. The fact that the recall was provoked by clinical outcome data points to the potential power of implant registries in regulating surgical implants.
Boston Scientific Claims Its U.S. Defibrillators Enjoy Increased Longevity. FDA Agrees
The U.S. FDA has approved revised product labeling for the Boston Scientific Corporation INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices.
FDA 510(k) Clearance for ViewRay’s MRI-Guided Radiation Therapy System
Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.
FDA Clearance For Endoscopic Gastro-Oesophageal Reflux Disease Device
Israeli device company Medigus Ltd. has announced that it has received FDA 510(k) clearance for its SRS endoscopic system, designed for minimally-invasive endoluminal treatment of Gastro-oesophageal reflux disease.
Blunt-Tip Suture Needles. Your Life “Still” In Your Hands… Twenty Years On.
Convincing a surgeon to use a blunt suture needle is akin to asking him to ditch the Aston Martin in favour of the Micra. It’ll work, but not in quite such a satisfying way. Maybe FDA can do a better job than we did twenty years ago when even HIV/AIDS didn’t prove convincing.
Medical Device Alert: GEMSTAR™ Bolus Cord For Use With GEMSTAR™ Infusion Pump
UK MHRA has issued a Medical Device Alert (MDA) pertaining to the GEMSTAR™ infusion pump manufactured by Hospira Inc. It seems the accessory Bolus Cord can become damaged and consequently fail to deliver requested medication to the patient.
UK NICE Supports Use Of Pipeline® Device For Treating Patients With Complex Brain Aneurysms
NICE, the healthcare guidance body, has today issued guidance supporting the use of Covidien’s Pipeline® device for the treatment of complex brain aneurysms.
St.Jude Amplatzer® Septal Defect Occluder: What FDA Really Wants
FDA’s circulatory devices panel review meeting last week, a routine scheduled event, has been widely reported as ordering some sort of panic stricken review of St.Jude’s Amplatzer® device. The reality was altogether less of a headline grabber.