Cardio

Neovasc Inc. has announced that a first patent covering the company’s innovative Tiara™ transcatheter mitral valve replacement technology has been issued by the US Patent and Trademark Office. The new patent protects key aspects of the Tiara mitral valve prosthesis.

German heart device specialist Miracor Medical Systems GmbH has announced that 30 patients have been successfully treated with no device-related adverse events using its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System. PICSO is a rather clever system, designed to improve myocardial perfusion following primary PCI.

Medtronic’s Lead Integrity Alert software is designed to detect implantable pacing lead failures better than impedance monitoring alone. Now the company has gained FDA approval for its system to be used in the detection of problems with other manufacturers’ leads, which opens up a further 12,000 case in the US alone.

While all the big cardio companies are focusing on valves, one developer has come up with an innovative approach to accessing the operative site in a safe, quick and easy way. We update the first clinical case, which took place live during EACTS in October.

Biotronik has seen its clever, electrospun coated stent gain CE mark approval for use in cases of acute coronary vessel perforation. The clever part lies in the electrospinning, which creates a single, integrated coating without the need to sandwich the stent.

Medtronic is no doubt hoping that by casting the net a little wider it may ultimately gain an indication for its Symplicity Renal Denervation System to be used on patients with less severe uncontrolled Hypertension.

Medtronic is trumpeting quite a landmark with the publication of a first head-to-head randomized controlled trial of “third-generation” durable-polymer drug-eluting stents for the treatment of coronary artery disease in an “all-comers” patient population. Resolute Integrity’s greater longitudinal strength doesn’t seem to play out in better target vessel failure stats.

It’s ironic that an embolus filter should find itself the subject of a recall for presenting a risk of embolus. It’s also reassuring that the company, Edwards Lifesciences, should take such a prudent step without having identified a single occurrence of the risk for which its device is being recalled.

Four year results from a randomised study suggest Biosensors’ BioFreedom™ polymer free, drug coated stent, demonstrates similar outcomes as Boston Scientifics’ drug eluter, Taxus™ Liberté™. The conclusion is that BioFreedom seemingly represents a good option for patients not able to tolerate long term DAPT.

Elixir Medical has seen one year results from its pivotal study presented at TCT2013. And impressive they are too, with luminal area sustained and low MACE rate.

FDA’s Mitraclip approval now means it’s available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. New data at TCT2013 provides compelling clinical support for the device in this patient group.

At TCT2013 this week InspireMD, Inc., has announced new 12-month study data which, it says, demonstrates that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.

Data presented at the TCT2013 symposium indicates that patients with drug-resistant hypertension treated with the EnligHTN™ Multi-Electrode Renal Denervation System averaged a 24 mmHg reduction in systolic blood pressure as measured in an office setting.

Transcatheter heart valve innovator, Direct Flow Medical®, Inc., has seen six month implant data presented at the TCT2013 congress, from the now fully-enrolled DISCOVER CE Mark Trial. A company press release says the results continue to affirm the excellent outcomes and strong safety profile of the company’s Transcatheter Aortic Valve System.

MIS device company, AngioDynamics has gained CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.

Boston Scientific’s Lotus™ Transcatheter Aortic Valve Implant has gained CE Mark approval as a treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.