Medical Devices Today

Mpathy Medical Devices Ltd.

Article preview from Start-Up - June 2008

Mpathy Medical Devices is focused on one of the hottest medtech markets--women's health. The company's physiologically compatible and ultra-lightweight Smartmesh technology targets the female anatomy to treat urinary stress incontinence and pelvic organ prolapse. Although Smartmesh is based on the same polypropylene material that has been used as mesh by other companies for many years for hernia repair and pelvic floor reconstruction, Mpathy Medical has innovated certain characteristics that encourage new tissue growth. Find out more.

ART: Bucking the Trend in Bioabsorbable Stents

Article preview from IN VIVO - June 2008

Bioabsorbable stents arouse great enthusiasm among both interventionalists and industry executives, because they have one major advantage over current stents, both bare metal and drug-eluting: they obviate the need for a permanent implant when only a temporary scaffolding effect is needed. Many stent companies are hedging their bets, working on stents that incorporate both drug elution and bioabsorbability--but not Paris-based Arterial Remodeling Technologies, which is arguing that natural healing, not drug therapy, is the best approach to therapeutically active stents.

Active Lead Launch

Full brief reprinted from "The Gray Sheet" - June 23, 2008

Medtronic will launch what it describes as the "first-ever active fixation left-heart lead" for cardiac resynchronization therapy later this summer following a recent PMA approval. The Attain StarFix OTW 5-French lead relies on pliable polyurethane lobes that can be relaxed by a physician following lead placement to reposition the device in a manner that significantly lessens the risk of dislodgement, the firm says. The lead can be used with any Medtronic CRT defibrillator.

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Medtronic Debuts Vision 3D Cardiac Devices

Brief Reprinted from "The Gray Sheet," May 19, 2008

Medtronic unveils its latest line of wireless implantable cardiac devices at the Heart Rhythm Society annual scientific sessions May 14-17 in San Francisco. The first devices to launch on the new Vision 3D wireless device platform are four implantable cardioverter defibrillators (ICDs) and two cardiac resynchronization therapy defibrillators (CRT-Ds), FDA-approved in April and expected to be commercially available in the "coming months." Additional Vision 3D platform products, including pacemakers and bi-ventricular pacemakers, will follow, the company said. Vision 3D technologies include Complete Capture Management to capture data from the right atrium and both ventricles of the heart, and adjust stimulation to patient needs. Other available Vision 3D features include: Conexus wireless telemetry via the CareLink network; the PainFree shock reduction feature, including ATP (anti-tachycardia pacing) During Charging; MVP managed ventricular pacing to reduce unnecessary pacing; and OptiVol to measure fluid levels in the thoracic cavity. Vision 3D "creates synergies across the platform so there's a common foundation across all the devices," Medtronic explains.

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OrbusNeich Says "Bio-Engineered" Stent May Be Solution To Thrombosis Risk

From the May 28, 2007, issue of "The Gray Sheet"

OrbusNeich hopes to lead a new wave of stent technology with its Genous Bio-engineered R-Stent, which the firm says is safer than existing drug-eluting stents because it has a natural antibody coating instead of a drug-eluting polymer.

David Camp, OrbusNeich's VP-strategic marketing and business development, spoke to "The Gray Sheet" about the device's potential May 23 from Barcelona, host of the EuroPCR conference May 22-25.

Genous was CE marked in August 2005 and is being evaluated in a number of studies in Europe. The Hong Kong firm met with FDA in March to discuss a pivotal trial to support U.S. approval of the device.

Edwards Set To Launch "Two-Trials-In-One" For Sapien Percutaneous Valve

From the March 26, 2007, issue of "The Gray Sheet"

Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says.

Announced March 20, FDA clearance allows the company to enroll the first 40 patients at up to eight centers in the PARTNER trial (Placement of AoRTic traNscathetER valves). Edwards plans to expand the trial to 15 additional sites, pending FDA clearance.