Techniques

Teleflex says its Arrow® VPS replaces the need for confirmatory chest X-ray by using state-of-the-art, real-time intravascular Doppler, ECG and advanced algorithmic logic to notify the clinician that the central catheter tip has reached the optimal location.

Medtronic, Inc. has announced findings from a health-economic analysis published online before print in The Journal of the American College of Cardiology that suggest the company’s Symplicity™ renal denervation system is a cost-effective treatment strategy for patients with treatment-resistant hypertension.

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.

German Neurovascular device company Acandis, has announced the CE mark approval of its novel Acclino® 1.9F low profile stent system, designed for use in the interventional neurovascular field as an adjunctive product in treating intracranial aneurysms with coils.

Registry data presented at ESC suggests MitraClip use is gathering pace, at least for the oldest and sickest patients for whom it is providing an alternative to surgical valve repair.

GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

EndoStim B.V. has announced CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter muscle.

Florida based autologous solutions company Biologic Therapies has gained FDA clearance for its Bio-MAC™ Bone Marrow Aspiration Catheter which it claims will enhance physicians’ use of autologous Bone Marrow Aspirate Concentrate in surgical procedures for the treatment of orthopedic conditions.

First randomized controlled study comparing Benvenue’s Kiva VCF treatment system to Medtronic’s Kyphon Balloon Kyphoplasty concludes ahead of schedule – Pre-defined criteria for early Stopping of subject enrollment met.

In the fight against AIDS, male circumcision is a key contributory factor in preventing female-male transmission. A simple device could offer the best chance of attaining targeted circumcision rates in Africa, mostly because it is simple and non surgical.

Codman Neurovascular, Inc., has announced the launch of the DELTAMAXX™ Microcoil System, ORBIT GALAXY® G2 Microcoils, and ENVOY DA Guiding Catheter at this year’s SNIS meeting in San Diego.

Cook Medical has announced general availability of the Aprima Access Nonvascular Introducer Set, the first product in the Aprima drainage portfolio. The system is purpose-designed for nonvascular single-puncture percutaneous access to facilitate placement of a working wire guide for interventional radiology procedures.

Nice product, well done for the CE Mark, but should Lazarus Effect be issuing a press release when it’s website’s not even finished? As medtech marketers we’re stumped why anyone would do that.

EquinoxO2 Medical, developer of negative pressure wound therapy foam dressings and pump systems, has announced introduction and distribution of its HALO XP npwt pump system.

MIS Sacroiliac joint specialist SI-BONE, Inc. has issued a press release announcing that it has reached a significant milestone for its iFuse Implant System® with over 3,000 patients implanted. The device is used to minimally invasively fuse the sacroiliac joint.

9 patient deaths are reportedly linked with catheter entrapment when delivering Covidien subsidiary ev3’sOnyx injectable embolic material into the brain. FDA has seen fit to warn users of the potential for this to occur.