Implantable Defibrillators

St.Jude and AorTech’s disputes are developing into an interesting story as the two parties home in on what looks like an inevitable termination early next month. Or, in what may look like rather a long shot at the moment, it may end up as an acquisition.

What could have provoked Scottish company AorTech issue proceedings against a St.Jude division? Whatever it was, S.Jude will be keen to draw a line under it, given that the agreement relates to the polymer used in its Durata lead coating.

It’s looking like Boston Scientific Week with more news about launches or approvals. The FDA has approved Boston’s S-ICD® System, which we seem to remember triggers a big fat earn-out payment to Cameron Health following its acquisition earlier this year.

Reliance® 4-Front™ Lead is designed to streamline surgical procedure for implantation of ICDs by improving handling and simplifying implantation.

In a strikingly heartwarming example of humanity charities already exist to coordinate the distribution of usable, explanted pacemakers from deceased Americans to less fortunate people in the developing world. A new study suggests this is a safe and viable practice, although the manufacturers disagree, citing concerns over reprocessing practices.

The first patient has now been enrolled in the Biotronik-supported study which aims to identify risk factors that can help predict appropriateness of ICD interventions.

FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.

A unique algorithm in Biotronik’s Lumax 740 ICD differentiates atrial from ventricular arrhythmias to avoid risk for potential long-term medical consequences of painful and inappropriate shocks.

St. Jude Medical, Inc., has gone public with initial findings from its Riata Lead Evaluation Study. The study’s phase-one results found that externalised conductors occurred in 9.3 percent of the smaller-diameter Riata ST 7F leads in the study, and in 24 percent of the larger-diameter Riata 8F leads.

St.Jude must have issued a corporate sigh of relief when its investigators concluded that the recently reported incidence of Durata ICD lead failure was most likely caused by abrasion from another lead or indeed a calcified structure, rather than the inside-out abrasion which has characterised the company’s Riata family problems.

Boston Scientific has finalised its acquisition of Cameron Health and in so doing adds the first and only commercially available subcutaneous “leadless” ICD technology to its portfolio.

ICD lead session at Heart Rhythm meeting, as reported by cardiac electrophysiologist John Mandrola, sounds like it gave the subject a thorough going-over and concluded that St.Jude’s Durata appears to significantly outperform its predecessor, while not yet having a big enough body of data behind it to convince the naysayers.

Hong Kong Doctor Wing-Hong Fung has performed the first Asian implant of Biotronik’s MRI compatible ICD, a device which acknowledges that heart patients may also need MRI at some point.

Champagne corks will be popping at Cameron Health as FDA’s expert panel review results in a vote in favour of its subcutaneously implanted S-ICD® device. FDA approval is expected to follow within 12 months.

April 26th is FDA Circulatory Panel decision day for Cameron Health’s S-ICD device. Not much resting on it… only $150m.

St.Jude is making a big deal of the fact that it sought guidance from 200 physicians on the design of its newly CE marked Ellipse ICD device.