Pardon our irreverence, but there’s a sitcom in here somewhere. The automated “housecall” is an obvious component in the provision of tomorrow’s healthcare, but the potential to get it wrong presents a minefield in which only certain patients with certain conditions will form the first wave.
USA
First Patient Supported with Abiomed’s Impella cVAD™
Promising signs for Abiomed as its percutaneously delivered high flow pump does the job for its first patient.
Now FDA Issues Class I “Recall” For Thoratec Ventricular Assist Device
FDA draws attention to potential problems with Thoratec’s HeartMate II LVAS pump.
Heart Rhythm 2012, Boston, May 9th-12th
Heart Rhythm 2012 is looking into view. Wonder if they’ll mention ICD leads.
FDA Clears Expanded Indications For Anulex’s fiXate™ Tissue Band
Useful little device, fiXate™ from Anulex Technologies Inc., has now had its indications extended by FDA, allowing for its use in securing intrathecal pain pump catheters.
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.
More Cold Water Poured On Consumer Reports’ “Dangerous Devices” Hyperbole
When it comes to Medical Device Regulation, a balanced assessment without fear nor favour is all we were looking for, so its refreshing to see someone else trying to counter the media frenzy.
Heart Blog Rather Sums It All Up
Thoughtful and insightful blog post from today on theheart.org
Medtronic Settles Shareholder Class Action Over Infuse
Medtronic settles its shareholder class action lawsuit for $85M.
FDA Expert Panel To Convene In June Over Metal-On-Metal Hips
It looks like it’s invitation only for the FDA panel review meeting to be held in June, at which experts will discuss all aspects of the Metal-on-Metal hip disaster.
FDA Clears Soma’s AxoTrack™ Needle Visualisation System
Soma’s Axotrack looks like a compelling, ultrasound-guided solution to the challenge of accurate needle placement. The company’s two newly FDA cleared applications suggest the agency agrees.
Biotronik’s Baseball “Hall-Of-Famer” Brand Ambassador. It’s Just Not Cricket
A piece of beautifully crafted PR sees ICD company Biotronik endeavour to benefit by appointing an implantee sporting legend as its brand ambassador. Great initiative, but a shame they chose the second most boring game in the world.
59th AORN In New Orleans
AORN is the biggest Perioperative nursing show on the planet and is being held in New Orleans from March 24-29.
J&J Selling Vaginal Mesh Without FDA Clearance Might Make A Good Headline, But Doesn’t Change Much
Vaginal Mesh problems are going to land at someone’s door and J&J’s looking like a soft target. It transpires the company decided to launch “Prolift” in 2005 as an “insignificant change” to a previous device, so didn’t feel the need to tell FDA about it.
New Report Predicts Price Pressure Will Hold Back US Large Joint Market Growth
Millennium Research Group predict modest growth in large joint market as price pressure waters down procedure growth.
Everflex: FDA Releases Summary Documents
FDA has now released summary information relating to last week’s newly US-cleared Everflex peripheral vascular stent from Covidien.