Vascular

One year data in the European multicenter clinical study into use of the VenaSeal Sapheon Closure System has yielded results that suggest it works and didn’t require recanalization in a single patient.

Cardio/Vascular device specialist Volcano Corporation has joined the list of companies issuing their fourth quarter and full year results for 2013. Quarterly revenue was up 6 percent on a constant currency basis, but losses increased dramatically as the company accounted for significant restructuring charges in the period.

Some outstanding sales figures from tissue sealant, hemostat, vascular and preservation services businesses underpin annual revenue growth of 7 percent.

Varicose Vein treatments typify the adoption of new technologies, factors such as economics, reimbursement and clinical resistance all playing their part in ensuring that the old ways, while in decline, will endure for a while yet.

Medtronic has initiated the European launch of the TOTAL across crossing catheter, which recently received the CE Mark as a tool for improving blood flow through narrowed or occluded lower-extremity arteries, including those in the especially challenging below-the-knee (BTK) vessel bed.

It’s a clever idea to constrain inflation of a PTA balloon along its length, because it avoids the worry of local vessel dissection. Registry results, reported at LINC 2014 last week, suggest the Chocolate® device works in a variety of peripheral artery disease conditions.

Two-year data has shown that Veryan Medical’s BioMimics 3D stent , with its unique three-dimensional helical geometry, provides an improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention for symptomatic peripheral arterial disease.

J&J Subsidiary, Cordis Corporation has seen two-year data from its INNOVATION Trial presented at the 2014 Leipzig Interventional Course in Germany. Data from the study continues to demonstrate that the INCRAFT® System performs well in patients suffering from abdominal aortic aneurysms (AAA) two years after treatment.

Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.

AtheroMed has announced the FDA’s clearance to market the Phoenix Atherectomy System, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.

ReCor Medical’s Paradise Renal Denervation System uses ultrasound energy to do the job, compared with the RF used by its major competitors. In the wake of Symplicity HTN-3’s poor results, ReCor is keen to put some fresh air between its approach and that of the opposition, pointing to favourable outcomes in patients who had already been treated with RF energy.

Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.

Cardiovascular device company Biotronik is in the news again with the announcement of its release of the Passeo-18 Lux Drug Releasing Balloon (DRB) in all countries accepting CE mark, following recent CE approval.

Global Pharma company Shire plc, is to sell what it calls its “Dermagraft assets” to Organogenesis Inc. for what could add up to $300 million, but for now looks like a $650 million loss.

Endovascular robot company Hansen Medical met its 2013 outlook for commercialization of systems and estimated procedures. Furthermore the company added two hospitals to its roster of Magellan Centers of Excellence in the U.S. for the training of physicians and medical staff.

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.