Medical Devices Today

Cutting Edge Spine LLC

Article preview from Start-Up - May, 2012

Cutting Edge Spine LLC has adopted a “less material” and “more open” engineering design philosophy to create its E-Vol family of interbody spacers. The start-up aims to offer implants that provide maximum bone/bone interface, loading and structural support and stability, to become a functional, integral part of the spine.

Renal Denervation Sparks Device Market Gold Rush

Article preview from Medtech Insight - May, 2012

With the recent success of Ardian’s Symplicity Renal Denervation System, drug-resistant hypertension has emerged as something of a device market “gold rush.” Some observers estimate there are now as many as 40 companies developing various device-based therapies for resistant hypertension, including most of the big names in the cardiovascular device arena – Medtronic, St. Jude Medical, Boston Scientific, Johnson & Johnson, and Covidien PLC – along with a number of start-ups, all of which are racing to stake a claim in this highly promising market. Only time will tell which companies will be successful – even Medtronic, the first player, has yet to complete its sham-controlled US trial. But the technology’s early promise, along with the sheer size of the opportunity and the acute unmet need, clearly have peaked the interest of investors, manufacturers, and physicians alike, all of whom are chasing after what one participant has called “the next biggest thing in cardiology.”

Orthofix Spin-Out Presents Another Opportunity For Private Equity

Article preview from IN VIVO - May, 2012

A handful of orthopedic companies are combating sluggish markets by sticking with what they know best – selling hip and knee implants. This has created a robust opportunity for private equity investors looking to build businesses in orthopedics peripheral markets. Health care-focused PE firm Water Street Healthcare Partners last month made the latest move by agreeing to buy Breg Inc., the sports medicine business of Orthofix International NV, for $157.5 million or 1.5 times 2011 revenues of $103 million.

House Passes Compromise User Fee Bill; Senate To Vote This Week

Article preview from "The Gray Sheet"-  June 25, 2012

The final bill includes device user fee reauthorization and additional FDA reforms, including a streamlined device reclassification process that has some in the device industry nervous.

Stroke Devices: Innovation Drives Growth

Article preview from Start-Up - May, 2012

Innovation is driving double-digit growth in the neurointerventional device market as an increasing number of medical device manufacturers develop newer, more effective devices for treating acute ischemic stroke. As new, stent-like retrieval systems and other next-generation neurothrombectomy devices hit the US market in the next few years, competition in this sector will also heat up as manufacturers try to differentiate their devices and jockey for a piece of the market, which is projected to reach almost $70 million by 2015.

Trends In MIS, Part I: Pushing Surgical Boundaries

Article preview from Medtech Insight - May, 2012

The market for minimally invasive surgical products continues to grow, driven by increasing demand and advances in laparoscopic technologies and techniques. Medical device manufacturers are developing new and innovative endomechanical and energy devices, as well as improved camera systems, which are allowing surgeons to safely push surgical boundaries and expand the minimally invasive surgery (MIS) approach into more complex surgical procedures than ever before. From a market perspective, manufacturers are driving growth in the MIS product market by targeting underpenetrated and emerging markets, particularly in Asia and Latin America, and by focusing education, sales, and product development efforts on growing clinical areas with good potential for increasing MIS adoption.

Neuronetics Brightens Outlook For Neuro Devices

Article preview from IN VIVO - May, 2012

Neuronetics Inc. forged a new specialty of sorts, the interventional psychiatrist. Unlike other interventional approaches, the externally applied NeuroStar delivers transcranial magnetic stimulation to the precise area of the brain responsible for intractable depression. The device is changing the lives of psychiatrists who launched “TMS” clinics, hoping to capture the early success, and potentially creating opportunities for medical devices designed to treat other brain-related disorders.

CMS Makes Policy Waves With Pullback Of Longstanding TENS Coverage

Article preview from "The Gray Sheet"-  June 18, 2012

The new finalized coverage policy for transcutaneous electrical nerve stimulation for treating chronic back pain is a rare decision by the agency to reverse coverage on an established technology, and is a new direction for the coverage-with-evidence-development program, observers say.

 

Transcatheter Technologies GMBH

Article preview from Start-Up - May, 2012

A major limitation of existing transcatheter aortic heart valves is that they are unable to be repositioned once implanted. For these devices, the valve is mounted in a metal stent that contains a balloon, which is inflated once the valve is placed. The valve is then anchored to the heart wall. Transcatheter Technologies GMBH believes its fully repositionable Trinity valve will solve this shortcoming. Once Trinity is initially placed, cardiac surgeons or interventionalists can evaluate the valve function to determine whether the valve needs to be repositioned, retrieved or kept in the same position. Moreover, it allows for a controlled positioning, by slowly opening the valve stent, for a likely first-attempt correct placement.

Dermatologists See Expanding Role For Energy-Based Treatments

Article preview from Medtech Insight - May, 2012

The market for aesthetic laser technology has been growing in the past few years, as the public searches for the perfect combination of low-priced, minimally invasive treatments that promise to restore a more youthful appearance. Dermatologists are the key medical practitioners in this field, and although many physicians have been happy to add new, revenue-producing therapies, the lack of extensive clinical data - particularly in the area of laser-liposuction - is a source of concern for a number of doctors.