Cardio

Q3 revenues for Sorin are somewhat clouded by last year’s earthquake which saw supply of some of its core lines temporarily suspended. A year later and the Italian cardiac device maker is recovering nicely as revenues return to pre-disaster levels and above.

Arterial Remodeling Technologies has seen early data concerning its “dismantlable” temporary coronary stent presented at TCT2013. It seems the device is maintaining its integrity at 30 days, with low vessel recoil rate akin to metallic stent performance. Next data points will be more interesting, however reassuring this early data is.

Micell’s MiStent SES is a unique concept in which the eluting drug outstays the carrier polymer. The theory is that this should afford longer term protection against inflammation and stenosis, and new data, presented at TCT2013, provides clinical support for the claim.

German transcatheter aortic valve developer, Transcatheter Technologies GmbH, has announced the successful first-in-human implantation of its transapical TRINITY aortic valve. Results will be presented on Monday at TCT2013. The company says it’s device is designed to be the best repositionable heart valve. Bold claim.

Back in March things were looking a little up in the air for MitraClip as the FDA’s circulatory devices panel gave the clever device its thumbs up, despite the FDA’s summary document at the time saying there were still concerns. Seven months on and the device has received its US approval and will launch immediately in the United States.

Infraredx, Inc. describes its TVC Imaging System™ as being capable of the true vessel characterization of coronary artery disease. The system will be highlighted in 13 presentations during the annual Transcatheter Cardiovascular Therapeutics Meeting which starts this Sunday in San Francisco.

Boston Scientific is never far from the news and this week is no exception as the company gains a prestigious award for its recently acquired subcutaneous ICD technology. At the same time news was released that its ongoing restructuring plans are likely to result in up to 1500 job losses.

Cardiovascular Systems, Inc. has received FDA PMA approval for its Diamondback 360® Coronary Orbital Atherectomy System, the first such device to gain approval as a treatment for severely calcified coronary arteries for over twenty years.

TCT2013 will see St. Jude Medical, Inc. showcasing its newly FDA approved ILUMIEN™ OPTIS™ PCI Optimization™ System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease.

Oh they’re good these guys: Another patient story from SynCardia details Omer Bayrak, the first patient in Turkey to be discharged from the hospital with his SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver. Mr. Bayrak has returned to work and can even handle a quad bike.

Medtronic, Inc. has announced the U.S. launch of its Export Advance aspiration catheter, which it says offers greater power and superior deliverability in coronary artery thrombus removal.

The FDA has issued an alert to health care providers and patients concerning its Amplatzer Atrial Septal Occluder (ASO). It seems that in very rare instances, tissue surrounding the device can erode, resulting in life-threatening emergencies that require immediate surgery.

This time last year the news was filled with externalising ICD lead discussions, focusing to a large degree on St.Jude Medical. It seems a raft of clinical data has helped minimise the negative impact, while a healthy sales line and two exciting new acquisitions mean the company’s financial report is a positive sounding affair.

St.Jude Medical says newly acquired Nanostim’s leadless pacemaker represents one of the most important advances in the history of pacing technology. The deal could cost it $188m

The U.S. FDA’s Circulatory Systems Devices Advisory Panel has narrowly voted (4 vs 3 with one abstention) that biventricular (BiV) pacing with Medtronic, Inc. devices is beneficial for treating patients who have atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, compared to conventional right ventricular pacing.

A customer complaint investigation uncovered a potential problem with Edwards Lifesciences’ EMBOL-X Glide Protection System. It seems incidences of a bent tip may present a risk of breakage and subsequent embolization, so in the UK at least the company has issued a recall notice for certain batches.