Cardio

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.

German company Cardionovum GmbH has updated us with the news that its distribution network, covering 57 countries, is pressing ahead with the commercialisation of its Primus® paclitaxel-coated balloon based on preclinical and clinical support.

SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, announced today that revenue and implants for the first nine months of 2012 have exceeded the company’s best 12-month totals to date.
PR Newswire (http://s.tt/1pMln)

Boston Scientific is to acquire Rhythmia Medical, Inc. as it seeks to build its position in cardiac rhythm management. Rhythmia is a developer of mapping and navigation systems for cardiac ablation techniques and expects to have products in market next year.

Boston Scientific has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus™ Valve System and the results are expected to be used to support CE mark and other international regulatory approvals.

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.

TAVI is a great case study in technology adoption, most strikingly pointing to post-market data in the form of registries as a window on real world use of a technique which actually makes for a pretty compelling endorsement of EU regulatory rules.

It’s not often we get to cover a story from Slovenia, so here’s one with the news that SynCardia Systems, Inc.has announced that a Slovenian patient fitted with its temporary Total Artificial Heart, has now received a donor heart after 256 days of life with the device.

Medtronic’s new design multi-electrode radiofrequency renal denervation system builds on experience with the Symplicity™ Renal Denervation System.

Cardiac Science Corporation, a global leader in external defibrillation, diagnostic devices and monitoring systems, has unveiled the Burdick® 4250 Holter recorder—a wearable heart monitor half the size and weight of its Holter recorder predecessor.

Sunshine Heart Inc. has announced that it has received conditional approval from the FDA for an Investigational Device Exemption for its flagship C-Pulse extra-aortic, counter-pulsation, heart assist device.

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.

Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration clearance for the Emerge™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter and has begun marketing the device in the United States. The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability for physicians to address challenging lesions in coronary arteries. Both the Monorail® and Over-The-Wire (OTW) options are available. The Emerge Catheter has been commercially available in CE Mark countries since earlier this year.
PR Newswire (http://s.tt/1ov7B)

InspireMD, Inc. has announced that Ofir Paz, co-founder, board member and Chief Executive Officer of InspireMD since its founding in 2005, intends to step down as CEO as part of a planned transition to prepare the Company for formal commercialisation of its proprietary MGuard™ Embolic Protection Stent (EPS) platform technology for patients with Acute Myocardial Infarction.

Stentys is a French-headquartered medical technology company commercialising the world’s first and only self-apposing stent to treat Acute Myocardial Infarction (AMI). The company has announced the European commercial release of an enhanced stent-delivery system for its Self-Apposing® stent. The change involves use of a new catheter to implant the stent, which has a hydrophilic coating and an ergonomic handle that considerably facilitates stent implantation in tortuous vessels.

Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.