Medical Devices Today

Neurovascular Market's Time Has Come: Stealthy Sequent Medical Unveils Strategy

Article preview from Start-Up - September 1, 2011

With foresight, good timing, or simply years of experience, the founders of Sequent Medical (who also founded MicroVention) are launching a new endovascular product in Europe just as large companies are signalling their interest in the space via acquisitions. For the treatment of cerebral aneurysms, Sequent has developed a novel device that combines the best attributes of embolization coils and flow diverters, its founders believe.

3WIN NV

Article preview from Start-Up - June 1, 2011

Technology originally developed for one of the most sophisticated and advanced active implantable medical devices - cochlear implants - has been key to the development of 3WIN NV's deep brain stimulation device. The Flemish start-up's neurostimulator Synapse is designed to reduce collateral stimulation through the precise delivery of an electrical charge; as well as record the neural response to better target therapy for movement disorders.

HRS 2010: Subcutaneous ICD Generates Excitement, Controversy

Article preview from Medtech Insight - June, 2010

In the years since the dawn of the ICD era in the 1980s, perhaps four expansions of the implantable cardioverter defibrillator have captured the imagination of electrophysiologists and signaled unqualified success for the major manufacturers of these life-saving devices. Now, a new generation of ICD--the S-ICD or totally subcutaneous ICD--has the potential to join those sophisticated devices as the next truly evolutionary development in the field. Interest in the S-ICD picked up steam this spring in Denver at the 31st annual scientific sessions of the Heart Rhythm Society, where researchers presented the latest clinical results with the device.

Given To Launch Next-Gen Colonoscopy PillCam In Europe In November

Full article reprinted from 'The Gray Sheet" - July 20, 2009

Given Imaging expects its PillCam COLON 2 endoscopy capsule will overcome many of the limitations identified in a recent clinical trial comparing its first-generation PillCam COLON to standard colonoscopy. Find out more...

FDA Panel To Review Atritech’s Watchman Stroke-Prevention Device

Full article reprinted from "The Gray Sheet" - April 06, 2009

Find out how FDA's Circulatory System Devices panel will meet April 23 to review a PMA for Atritech's Watchman minimally invasive stroke-prevention device for patients with atrial fibrillation, according to the company.

FDA Approves J&J’s Navistar ThermoCool For Atrial Fibrillation Ablation

Full article reprinted from "The Gray Sheet" - February 09, 2009

PMA approval Feb. 6, Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational became the first cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation.

Rapid Exchange In Cardiac Cath Space: Medtronic Launches, Abbott Sues

Full article reprinted from "The Gray Sheet" - November 3, 2008

Find out how Medtronic finally reentered the U.S. market with popular rapid-exchange (RX) coronary catheter delivery systems Oct. 30 after an eight-year absence, prompting an immediate patent infringement suit from Abbott.

WaveTec Prepares for a New Wave in Refractive Surgery

Article preview reprinted from Start-Up - September 2008

Refractive lens exchange is a mega opportunity in ophthalmology with the potential to serve the large patient populations with presbyopia and astigmatism. The category has been slow to take off, however, because current technology doesn't allow clinicians to meet, consistently and with confidence, the high expectations of new refractive surgery customers who are paying out of pocket for the benefit of great vision, at all distances. WaveTec has an enabling technology for a wide range of refractive surgeries to help clinicians and the many manufacturers of implantable intraocular lenses deliver on the promise of better vision.

St. Jude Medical To Launch "Confirm" Implantable Cardiac Monitor

Full brief reprinted from "The Gray Sheet" - September 15, 2008

St. Jude Medical plans an October launch of its Confirm implantable cardiac monitor, which received 510(k) clearance on Sept. 11. Find out more...

Edwards Launches Magna Mitral Heart Valve Following FDA Approval

Full article reprinted from "The Gray Sheet" - September 8, 2008

Find out how Edwards LifeSciences will launch its Perimount Magna Mitral heart valve immediately now that it has received PMA supplement approval.