Cardio

Back in May 2013 we covered the CE marking of Elixir Medical’s DESolve Novolimus Eluting Coronary Scaffold. Now a first commercial implantation has been performed in Germany.

Ventricular Assist Device company, HeartWare International, Inc., says it expects revenues for Q4 2013 to be approximately $53 million, bringing expected full-year 2013 revenues to approximately $208 million. This represents 87% revenue growth over prior year, signalling a strongly upward trajectory for the company.

Israeli device company MediValve has announced the FDA clearance and CE mark approval of its acWire™ Guidewire, intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices.

Could renal denervation’s effect really be all placebo? That is almost impossible to believe. But something’s afoot and investigators and commentators are already speculating about what that might be.

Edwards Lifesciences’ new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve.

So-called transendocardial delivery of stem cells has solid clinical evidence supporting it. And now it has a newly CE marked catheter that opens up the procedure to patients with enlarged, dilated hearts, widening the pool of patients who can benefit from the therapy.

TAVI developer Direct Flow Medical®, Inc., has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve in the same week that the company has announced completion of enrollment in its US feasibility trial in patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement.

Renal denervation therapy has had a bad day with the news that the biggest study and first to be sham-controlled, has not delivered its primary efficacy endpoints. Consequences for Medtronic’s Symplicity programme are serious enough for the company to be considering incurring an impairment charge.

The Society if Thoracic Surgeons has published a study which opens the door for Transcatheter aortic valve implantation (TAVI) to potentially be used in very elderly patients as an alternative to conventional surgical valve replacement.

We’ve covered TYRX’s clever antibacterial, FDA cleared, device envelopes before, mainly because it’s an interesting concept. Medtronic thinks so… it likes it so much it’s bought the company.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.

Afib device specialist AtriCure, Inc., has entered into a definitive merger agreement with Endoscopic Technologies, Inc. d/b/a Estech (“Estech”). AtriCure … continue reading “AtriCure Brings Estech into the Fold”

According to a well-known Berlin cardiologist, monitoring devices enable physicians to treat patients more effectively. The BioMonitor from BIOTRONIK is now approved for full-body MR scans.

The UK’s NICE Healthcare guidance and standards body, has published positive final medical technology guidance on the use of vascular device company Jotec’s E-vita open plus endoluminal stent graft device in the treatment of complex aneurysms and dissections of the thoracic aorta. By avoiding a second procedure the system removes risk and saves money.

Medtronic, Inc., has kicked off its SYMPLICITY HTN-4 study with the news that the first patients have been randomized. The study, which started enrolling in November 2013 will evaluate the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension

Boston Scientific has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems and seen first implantations in Italy.