St.Jude Medical’s Bi-Annual Product Performance Report highlights positive results for its Optim coated leads, while also accepting an ongoing problem with older Riata products.
Alerts/Adverse Events
Medical Device Alert: St.Jude Medical Left Ventricular Cardiac Resynchronization Therapy (CRT) Leads
More pacing leads from St.Jude are now at risk of externalisation according to a new MHRA medical device alert.
Medical Device Alert: Macrolane™Dermal Filler For Breast Augmentation
Not that breast implants set off any alarm bells or anything: Breast augmentation filler Macrolane may obfuscate the results of mammograms to the extent that its manufacturer has removed the indication and issued directions on how to treat patients with the filler in place. UK competent authority the MHRA has seen fit to issue an alert along the same lines to draw attention to it.
Transvaginal Mesh: Regulators Urged To Act More Decisively
A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.
St. Jude Counterpunches With Publication Of MAUDE Medtronic Lead 377 Death List
As public spats go, this one is going to take some beating. St. Jude is not looking like its in the mood to give up as it comes right back at Medtronic, Dr Hauser and Heart Rhythm.
Heart Rhythm Says No To St.Jude Request
Predictaresponse time. Heart Rhythm has refused to retract, which it was always likely to do. St. Jude might get the chance to respond in public as the journal offers to review its data.
Riata: Medtronic Joins War Of Words
It’s all getting a bit heated as Medtronic and St. Jude lock horns again, this time over the Hauser publication in Heart Rhythm journal.
St Jude Questions Hauser Paper And Demands Retraction
According to St Jude, Dr Robert Hauser’s paper, accepted for publication in the Heart Rhythm Journal is biased and inaccurate, comparing apples with pears and peddling conclusions it’s own analysis cannot reproduce from the data set. Watch this space.
St. Jude Medical’s “Externalisation” Woes Extend To QuickSite and QuickFlex LV CRT Leads
St Jude medical is taking the initiative over more of its leads in which so-called externalisation can result in problems, by issuing a physician advisory letter.
Heart Blog Rather Sums It All Up
Thoughtful and insightful blog post from today on theheart.org
Medical Device Alert: Finsbury Mitch TRH Cup/Heads Combined With Stryker Accolade Femoral Stems
UK MHRA singles out specific combinations of hip/stem for attention, this alert proving the value of the data in England and Wales Joint Registry.
Medtronic Settles Shareholder Class Action Over Infuse
Medtronic settles its shareholder class action lawsuit for $85M.
St Jude’s Brio™ Deep Brain Stimulation System Withdrawn For Fix
St Jude has recalled and suspended sales of its Brio Deep Brain Stimulation system until it resolves the issue of body fluid ingress, which it believes is causing a lack of therapeutic effect.
Medical Device Alert: Covidien LigaSure Dolphin Tip sealer/divider
Covidien in the news again, this time with UK recall of LigaSure Dolphin Tip Sealer for fear of loose pins in the handle.
Medical Device Alert: Medtronic EnTrust VR/DR/AT
UK’s MHRA issues a Medical Device Alert on Medtronic’s EnTrust ICD, which is at risk of losing charge.
FDA Recall: Acclarent Inspira AIR™ Balloon Dilation System, Size 18X40mm
Acclarent’s voluntary recall of its Inspira Air™ balloon dilatation system has been formalised as a FDA Class 1 recall.