Medical Devices Today

New Access Devices Create Gateway To Interventional Structural Heart Disease

Article preview from Start-Up - July, 2012

Now that transcatheter heart valves have been implanted in thousands of humans, it’s becoming clear where the problems lie. Vascular and bleeding complications, stroke and paravalvular leaks are the most troubling consequences. Most of the focus has been on improving the valves and the delivery systems, but now innovators are looking at the issue of access – the particular ways by which therapeutic devices enter the heart – and how it can be changed to improve outcomes. In this issue we profile Apica Cardiovascular, Entourage Medical and Inseal Medical.

Women's Health: Promising Advances, But Challenges Persist

Article preview from Medtech Insight - April, 2012

The field of women's health is one of the most progressive medical technology sectors in the US, driven by the aging population, diagnostic advances in deadly ovarian and colorectal cancer, and medical device innovations in gynecologic and urogynecologic disease management, including a shift toward minimally invasive surgery (MIS) techniques and robotics and the addition of a new field: bariatric gynecology. At the WH 2.0 Consensus Conference on Women's Health, held recently in Los Angeles, experts agreed that advances in medical technology are promising better detection and treatment of a host of diseases impacting both premenopausal and postmenopausal women. However, challenges remain in managing obesity-related disease and improving screening for often-undetected cancers in women.

Punctal Plug Can’t Keep QLT Afloat

Article preview from IN VIVO - July, 2012

Five years ago, QLT Inc. charged in hard and snapped up an experimental drug-eluting punctal plug technology created by incubator ForSight Labs LLC. At the time, we reported in START-UP that the punctal plug – designed to deliver drugs directly into the eye – might make or break the company. Looks like it was the latter. Last month, QLT’s newly elected board of directors instituted a broad reshuffling of the company. The board cut the work force by 68% and it intends to divest the still-experimental punctal plug technology, hoping to sell the line outright or spin it out into another entity.

Getting The Lead Out: Firms Need To Remove The Metal From Devices In EU By 2014

Article preview from "The Gray Sheet"-  August 27, 2012

The European Commission revised the Restriction of Hazardous Substances in Electrical and Electronic Equipment directive last May, and expanded its scope to include medical devices and in vitro diagnostics sold in the EU within the next two to four years.

Brainsway Closes Gap Between Devices And Drugs With Noninvasive Deep Brain Stimulation

Article preview from Start-Up - July, 2012

Following a series of private investments and strategic acquisitions, Brainsway Ltd. announced it had received CE mark approval for a new therapy for chronic neuropathic pain, bringing another potential neurostimulation treatment to market in Europe. Meanwhile, the company reported positive interim results on its clinical trial of a treatment for obsessive compulsive disorder, adding to positive results from a pivotal multicenter trial studying its therapy for major depression. These trials validate a new device treatment for conditions that neurologists and psychiatrists typically treat with drugs.

Smaller Players Find Opportunity In Large Joints

Article preview from Medtech Insight - May, 2012

Five companies control 95% of the market in hip and knee implants, creating an unfriendly environment for newcomers trying to grab a piece of their own. But economic and regulatory pressures are making things increasingly uncomfortable for the market leaders, giving hope to companies pushing new technologies and sales techniques.

ApniCure: Unmasking Sleep Therapy With An Alternative To CPAP

Article preview from IN VIVO - July, 2012

Sleep apnea is now widely recognized as an underlying factor for major CV diseases and metabolic disorders, making it a huge market opportunity. ApniCure hopes that by avoiding the CPAP masks that patients hate while using the differential pressure therapy that doctors and payors like, it can unlock this potential blockbuster market.

EU Directive Sets Recycling Targets, Shipping Requirements For Med Devices

Article preview from "The Gray Sheet"-  August 20, 2012

The recycling targets are likely manageable for companies who contract with established “compliance schemes,” says a Eucomed consultant. But the shipping requirements might be a burden, industry says.

The Evolving World Of Breast Cancer Management

Article preview from Medtech Insight - July, 2012

The device industry is playing a pivotal role in the evolution toward a more personalized approach to breast cancer management, with ongoing advances in minimally invasive treatment systems, tumor characterization and breast imaging technologies adding to the momentum. In the years ahead, as the breast cancer toolbox expands, the watchword will be “choice,” with physicians and patients offered more treatment options, targeted to their specific needs and desires, than ever before.

 

Loma Vista Medical Inc.

Article preview from Start-Up - June, 2012

With the clinical literature documenting the structural failure rate of standard balloon catheters for balloon aortic valvuloplasty and transcatheter aortic valve implantation hovering between 10 and 17%, there is definitely a need for a more durable balloon to prevent puncturing or bursting. Loma Vista Medical Inc. thinks its recently launched TRUE Dilatation balloon meets the unique requirements of TAVI. It is made of high-strength bulletproof fibers (a composite of seven different materials/layers) that are more effective than any one material alone and are ideal to handle high-structural loads.