Companies

Californian radiotherapy company Varian Medical Systems’ President and CEO Timothy Guertin has declared his intention to retire from the role after 35 years with the company.

Stryker Neurovascular’s Trevo® Pro Retriever has gained FDA 510(k) market clearance. The Trevo® Pro Retriever outperformed Stryker’s own Merci® Retriever in a clinical study first published in May, showing improved revascularisation compared with the older generation product.

J&J subsidiary business Ethicon Endosurgery has issued a voluntary recall of certain lots of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories. The recall was provoked by reports of difficulty firing the device although the company seems to have no problem doing so when reloading returned devices.

SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, has announced revenue for the quarter ended June 30, 2012, marking the company’s best quarter to date and its fifth consecutive profitable quarter.

TranS1’s technology is intriguing enough to keep on capturing our attention, but its revenue and gross margin picture for Q2 2012 are not painting a picture of growth. Encouraging words from the boss though.

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.

Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its HARMONIC ACE®+ Shears with Adaptive Tissue Technology. The company says this represents the next generation in its “best-in-class” HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs.

The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.

Orthopaedic extremity device company Tornier, N.V., has announced that it has appointed Shawn T McCormick as Chief Financial Officer, effective as of September 4, 2012.

A first patient has been successfully implanted with Medtronic’s DBS device as Functional Neuromodulation Ltd initiates the ADvance Study in the U.S. and Canada to assess the therapy in patients with mild Alzheimer’s disease.

Codman has announced receipt of U.S FDA approval through a PMA supplement for its MEDSTREAM™ Programmable Infusion System. MEDSTREAM is an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury.

Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. The stent, already CE marked and marketed in Europe, has passed muster with the FDA following a comparative multicentre clinical study which suggested it outperforms endpoints established from previous stent studies..

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.

Covidien has confirmed that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

With the opening of its new $45M facility Covidien’s investment in China is significant and a sure sign that the healthcare giant sees the Far East as the medtech powerhouse in years to come.