Regulatory

Vaginal Tape and Mesh problems continue to exist. UK competent authority the MHRA has issued a new document which endeavours to capture the state of play and provide guidance for surgeons in the NHS.

Boston Scientific will feel they have stolen some solid commercial ground with the news that, in Europe they can now claim extended life from their defibrillator ranges thanks to their new battery technology.

The FDA has published its inspection notes from recent visits to St.Jude’s Durata plant and they don’t make pleasant reading for the company. I dare say, if I was the FDA inspector and knew the history I might be a tad pedantic, but this lot reads like a catalogue of shortfalls.

The FDA has issued a Class I recall, it’s highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose.

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

The U.S. FDA has approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

CE mark for Harvest Technologies’ Bone Marrow Aspiration system means that, for the first time, European critical limb ischemia patients, at severe risk of amputation, now have a treatment option.

St.Jude Medical, Inc.says its newly CE marked transcatheter valve is uniquely re-sheathable prior to full deployment, so could potentially lead to improved, accurate placement and reduced paravalvular leak compared with the first generation products.

A fine example of how problems can befall a medical product. In this case, overzealous zapping (alright, gamma irradiating) one particular lot of an X-Ray detectable swab during manufacture has had the potential effect of causing its X-Ray detectable thread to fall to pieces.

Norwegian company Vitacon has announced the FDA 510(k) clearance of its clever non-invasive bladder scanner, which seems to tap into new reimbursement guidelines. The company has employed a U.S. partner to drive its commercialisation efforts.

Abiomed’s Impella® devices are fiendishly clever little pumps for use in heart failure patients. The company has now received FDA approval to commence an IDE study on its new Impella RP device which it hopes will pave its way to U.S. humanitarian device exemption.

We close pretty much every week feeling slightly frustrated that the world we live in, that of the observer of medical device companies, technologies and medical professionals, is not perfect. Trouble is the environment and its players don’t do much to improve things sometimes.

UK vascular device specialist Veryan Medical has developed a stent design technology which aims to mimic the helical shape of peripheral vessels in the hope that this will have a vasoprotective effect and furthermore reduce risk of deformation and vessel trauma during leg flexion.

Peripheral vascular disease treatments have shuffled under the spotlight in recent months with a seemingly endless trail of new devices and approvals for unblocking diseased vasculature. Now Cook Medical can say it has the first drug-eluting stent to be FDA approved for the job.

We don’t know what it’s about, but it’s obviously material enough to warrant Integra going to press with the news that it has received a warning letter from the FDA following the agency’s audit of its UK facility earlier this year.

Just over two years after it was CE marked, TriVascular’s Ovation Stent Graft, suitable for use in patients with small vascular access and challenging anatomy, has gained full approval in the United States.