Cardio

HeartWare International Inc. has announced revenue of $29.1 million for the second quarter ended June 30, 2012, representing a 42 percent increase from $20.4 million in revenue for the same period of 2011. However the company recorded a net loss more than double prior year as it invested in R&D and commercialisation activity.

Cardiac telemedicine specialist CardioNet, Inc. has entered into a definitive merger agreement with cardioCORE Lab, Inc., a leading centralised cardiac testing laboratory. The move is seen as exploiting an adjacent market, while de-risking by broadening CardioNet’s business base.

Circulatory support device company HeartWare International, Inc., has announced the closing of the acquisition of World Heart Corporation for a reported $8M in common stock, following the approval of the transaction today by World Heart stockholders.

Sunshine Heart tells us it’s come up with a device upgrade which will make its CPulse heart assist device run quieter and less bulky. The company awaits the FDA’s formal confirmation that it’s good to go, but the conditional approval has been announced. And the share price has gone up.

ART reckons its bioresorbable coronary stent will disappear in a predictable timeframe because of its “programmed transitory presence”. Despite the sci-fi language it sounds like a smart product if it works… time will tell as the company undertakes its first in man clinical study.

Edwards Lifesciences was not likely to let a BMJ article go unanswered, so it’s unsurprising to see the purveyor of the Sapien transcatheter valve issuing a stout defence of the clinical evidence behind its baby. But as a clinician, what are you supposed to do?… wait until the body of evidence is so significant as to be incontrovertible, or use your own judgement within the confines of regulatory approval?

Belgian researchers have stirred up a hornets nest with their assertion that evidence for TAVI means its use should be more limited than is the case, and furthermore that we’re still not getting the whole picture.

Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers

Is there enough newsworthy stuff happening in medtech to justify a weekly review? Oh yes.

Sunshine Heart, Inc. has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure.

Edwards Lifesciences Corporation has released its second quarter financial results which are, on face value, bucking the trend by showing sales growth of almost 16% (albeit excluding currency impact) to $482m compared with the equivalent period last year. Closer examination reveals that growth is almost exclusively related to the company’s Sapien transcatheter heart valve, launched in U.S and seeing continued growth internationally.

Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).

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.

US researchers have found that the irregular heart rhythms of atrial fibrillation are caused by small electrical localised sources or “hotspots” inside the heart called focal impulses or rotors. Now they can map these rotors and ablate them with a degree of accuracy which seems to render results which are twice as good as previously achieved.

Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning at the point of care.

Abbott has announced its financial results for the second quarter ended June 30, 2012. Reported sales increased 2.0 percent, including an unfavourable 4.7 percent effect of foreign exchange. Stent sales suffered due to the wind-down of the supply arrangement with Boston Scientific, but recent Xience news gives reason for optimism.