St Jude

Results from St.Jude’s RESPECT PFO trial presented at TCT 2012 show that the primary analysis was not statistically significant but trended towards superiority, while additional analyses demonstrated superiority.

It’s not all doom and gloom for St.Jude, but its hard to find much good news from the revenue lines. AF is the shining star from the sales perspective, and the bottom line has been tarnished by inclusion of costs associated with reorganisation

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.

Brilliant idea this. Use the principle behind your in car GPS to create the map of the internal organ, then fit your insertable device with sensors so you can locate it without repeat fluoroscopy. Real time navigation with reduced radiation exposure.

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.

Data published today in the Headache Society journal Cephalagia shows significant reductions in pain, headache days and migraine-related disability when Peripheral Nerve Stimulation therapy is applied.

St. Jude Medical, Inc. has announced it has received European CE Mark approval of its Eon™ family of neurostimulators for patients with intractable chronic migraine. The range includes the Eon Mini, which St.Jude says is the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class.

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.

UK regulatory authority the MHRA is very keen to ensure that all pertinent information on the management of the potential for externalised ICD leads, reaches the appropriate medical professional, so has issued a follow up device alert with updated guidance.

St.Jude has taken the radical decision to shoe-horn its previous four divisions into two. These will be called the Implantable Electronic Systems Division (IESD), which will encompass CRM and Neuromodulation, and the Cardiovascular and Ablation Technologies Division (CATD), which will encompass Atrial Fibrillation and Cardiovascular. 300 job cuts and a host of efficiency savings are anticipated.

Twenty eight point reduction of systolic blood pressure after one month remained stable at three months using EnligHTN renal denervation system according to ESC hotline session data.

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.

St.Jude’s CEO Dan Sparks used the word “favorable”(sic) to describe the outcome from its giant study into whether closure of a patent foramen ovale using the company’s Amplatzer device has a positive impact on incidence of cryptogenic stroke. Some commentators are suggesting he should have kept schtum until the clinical results are published later in the year.

St. Jude Medical, Inc. has reported sales and net earnings for the second quarter ended June 30, 2012. Compared with the equivalent period a year ago net sales of $1.410 billion represented a decrease of 2 percent, declines in Cardiac Rhythm Management sales being somewhat offset by increases in Atrial Fibrillation and Neuromodulation revenues.

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.