Medtech Insight from Elsevier Business Intelligence

Renal Denervation Sparks Device Market Gold Rush

Fri, 25 May 2012 01:30:00 -0400

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.

Trends In MIS, Part I: Pushing Surgical Boundaries

a.staylor@elsevier.com — Fri, 25 May 2012 01:00:00 -0400

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.

Dermatologists See Expanding Role For Energy-Based Treatments

r.neil@elsevier.com — Fri, 25 May 2012 00:03:00 -0400

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.

Smaller Players Find Opportunity In Large Joints

t.salemi@elsevier.com — Fri, 25 May 2012 00:02:00 -0400

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.

Medical Device Deals Update, May 2012

b.detuzzi@elsevier.com — Fri, 25 May 2012 00:00:00 -0400

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

Medical Device Market & Industry Briefs, May 2012

Fri, 25 May 2012 00:00:00 -0400

Brief summaries of recent medtech market and industry developments. This month we cover Hologic’s acquisition of Gen-Probe, highlights from Heart Rhythm 2012 and a wrap-up of life sciences venture capital funding for Q1 2012.

Washington Roundup, May 2012

d.filmore@elsevier.com — Fri, 25 May 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on the new Medicare coverage policy for transcatheter aortic valve replacement and Medicare latest hospital inpatient payment proposal.

Start-Up News, May 2012

bkronemyer@frontier.com — Fri, 25 May 2012 00:00:00 -0400

This month we profile Transcatheter Technologies, which is developing a repositionable TAVI implant, and Cutting Edge Spine, which has created a family of interbody spacers for spinal repair.

IN³ Medical Device 360° Boston

Sun, 29 Apr 2012 00:00:00 -0400

Publisher’s Spotlight: Elsevier Business Intelligence is pleased to invite you and your team to join us for Investment in Innovation (IN³) Medical Device 360° Conference, being held June 27-29, 2012 at the beautiful Hyatt Regency Boston in Boston, MA.

LAA Closure Devices: Reaching Critical Mass?

Wed, 25 Apr 2012 00:05:00 -0400

Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs.

Women's Health: Promising Advances, But Challenges Persist

tracyneilssien@yahoo.com — Wed, 25 Apr 2012 00:04:00 -0400

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 hos...

Deep Brain Provides Stimulating Market

m.stuart@elsevier.com — Wed, 25 Apr 2012 00:03:00 -0400

There are signs that the field of deep brain stimulation (DBS) has gained a certain momentum of late: three start-ups raised venture rounds in 2011 and there have been two acquisitions in the space within the past year. DBS enables the giants in cardiac rhythm management – Medtronic, St.

Medical Device Market & Industry Briefs, April 2012

m.thompson@elsevier.com — Wed, 25 Apr 2012 00:01:00 -0400

Brief summaries of recent medtech market and industry developments. This month we cover Covidien’s continuing buying spree, and other medtech M&A.

Washington Roundup, April 2012

Wed, 25 Apr 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover CDRH’s plans to expand its Medical Device Epidemiology Network and the potential impact of the JOBS Act on life sciences start-up companies.

Medical Device Start-Up News, April 2012

Wed, 25 Apr 2012 00:00:00 -0400

This month we profile OvaScience, which has a new approach for treating infertility in older women, and Bluegrass Vascular, which offers an “inside-out” catheter for central venous access.

Medical Device Deals Update, April 2012

b.detuzzi@elsevier.com — Wed, 25 Apr 2012 00:00:00 -0400

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

Expanding The EVAR Toolbox: A Glimpse Into The Future

m.thompson@elsevier.com — Wed, 28 Mar 2012 00:05:00 -0400

The US endovascular abdominal aortic aneurysm repair (EVAR) market is one of the most dynamic device segments in the interventional arena, with growth and innovation driven in large part by an accelerating effort to expand EVAR to a wider patient pool. This movement toward more challenging cases does have a downside in terms of potential complications and uncertain long-term durability as physicians push the envelope of existing technology.

Stroke Devices: Innovation Drives Growth

a.staylor@elsevier.com — Wed, 28 Mar 2012 00:04:00 -0400

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.

Percutaneous Mitral Valve Therapy: The Next Decade

m.stuart@elsevier.com — Wed, 28 Mar 2012 00:03:00 -0400

After more than a decade, the field of transcatheter mitral valve therapy is still in its infancy, yet it is surprisingly crowded. The first percutaneous mitral valve company was founded in 1999, the same year that the first transcatheter aortic valve implantation (TAVI) company was founded, but while TAVI is now on the market in Europe and in the US, the leading transcatheter mitral valve therapy has only just completed clinical trials.

Orthopedic Implants: Interest Expands In Reverse Shoulders

sharon@biomedgps.com — Wed, 28 Mar 2012 00:00:00 -0400

With the economy improving and the total joint market slowly recovering, one of the brightest spots in the orthopedics industry is the market for shoulder replacements. While 2012 growth rates of total hips and knees are forecast in the low single digits – at 3% and 1%, respectively – the US shoulder replacement market is growing at a brisk 9.7% pace and is expected to reach approximately $620 million in revenues this year.

Medical Device Market & Industry Briefs, March 2012

Wed, 28 Mar 2012 00:00:00 -0400

Brief summaries of recent medtech market and industry developments. This month we cover new scrutiny of metal-on-metal hip implants, new developments in reimbursement for carotid artery stenting, and a new report on shifting hospital purchasing patterns.

Medical Device Deals Update, March 2012

b.detuzzi@elsevier.com — Wed, 28 Mar 2012 00:00:00 -0400

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

Washington Roundup, March 2012

m.thompson@elsevier.com — Wed, 28 Mar 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposed comprehensive postmarket surveillance strategy, as well as updates on proposed 510(k) reforms and device user fees.

Medical Device Start-Up News, March 2012

Wed, 28 Mar 2012 00:00:00 -0400

Noteworthy news from medtech start-ups. This month we profile VasoStitch, which has developed technology for streamlining access and closure for transcatheter valve procedures, and ZipLine Medical, which has developed a noninvasive, external skin closure system intended as an alternative to sutures and staples.

IN³ Medical Device 360° 2012 - London

Thu, 08 Mar 2012 00:00:00 -0500

Publisher’s Spotlight: Elsevier Business Intelligence is pleased to invite you and your team to join us for The Investment in Innovation (IN³) Medical Device 360° Conference, being held April 25 - 26, 2012 at the beautiful Millennium Gloucester Hotel & Conference Centre in London Kensington.

Emerging Diabetes Technology Driven By Patient Demands

r.neil@elsevier.com — Fri, 24 Feb 2012 00:06:00 -0500

Integration has become a key driver in the development of a new wave of diabetes tools that have either recently hit the market or will become available in the next few years. Many diabetics, who have a great deal of influence on the success or failure of products in this space, are seeking devices that work seamlessly with the smart phones and cellular technology that are so prevalent today.

Device Trends To Watch In 2012

s.levin@elsevier.com — Fri, 24 Feb 2012 00:05:00 -0500

For much of the device industry, 2011 was marked by continuing change across the medtech ecosystem, most notably in the economy, the regulatory process, and the financing/innovation model. For 2012, we predict more of the same: the only certainty is continuing uncertainty.

Despite Setbacks, Emphysema Devices Find Funding

a.staylor@elsevier.com — Fri, 24 Feb 2012 00:05:00 -0500

Minimally invasive emphysema devices have seen their ups and downs over the years, but despite technological and regulatory challenges, VCs continue to fund these devices, with investments driven by the market opportunity, huge unmet clinical need, and promising technologies.

Diagnostic Industry Trends Hinge On Gene-Based Tests

m.ratner@elsevier.com — Fri, 24 Feb 2012 00:00:00 -0500

In 2011, sequencing was once again the big story in diagnostics. But unlike 2010 when the big news was the successful IPOs of next-generation sequencing companies Pacific Biosciences and Complete Genomics, the tone in 2011 was more nuanced.

Retinal Disease: Much Progress, Some Pain

Michael@LachmanConsulting.com — Fri, 24 Feb 2012 00:00:00 -0500

On many fronts, 2011 was an event-filled year for the retinal disease market, beginning with the publication of the CATT trial comparing off-label intravitreal Avastin versus Lucentis for the treatment of AMD, and ending with several important milestones for device manufacturers operating in this space. But while the retinal device field is making progress in many areas, companies continue to struggle to meet shifting FDA approval requirements.

Market & Industry Briefs

m.thompson@elsevier.com — Fri, 24 Feb 2012 00:00:00 -0500

Brief summaries of recent medtech market and industry developments. This month we cover news from the TAVI space, ConforMIS’ customized knee implants, and Siemens’ recent companion diagnostic dealmaking.

Deals Update

b.detuzzi@elsevier.com — Fri, 24 Feb 2012 00:00:00 -0500

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

Start-Up News

tracyneilssien@yahoo.com — Fri, 24 Feb 2012 00:00:00 -0500

Noteworthy news from medtech start-ups. This month we profile three emerging artificial retina developers: Nano Retina, 2C Tech Corp. and LambdaVision.

Washington Roundup

m.thompson@elsevier.com — Fri, 24 Feb 2012 00:00:00 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover the device industry’s reaction to doubled user fees, and new developments in medical device taxes.

Heart Failure Devices: Raising Roadblocks To Readmission

m.thompson@elsevier.com — Fri, 27 Jan 2012 04:00:00 -0500

A new Medicare cost-control program aimed at reducing costly hospital readmissions has heart failure squarely in the cross-hairs, and the consequences could mean hundreds of thousands of dollars in lost Medicare revenue for hospitals that fail to meet the new readmission standards. As a result, providers are scrambling to implement programs to assess and reduce heart failure readmissions, and a growing number of device companies are touting a variety of technologies they believe could help them achieve that goal.

Start-Ups Move Stem Cell Products Forward On Long Path To Market

r.neil@elsevier.com — Fri, 27 Jan 2012 03:00:00 -0500

The dream of turning stem cell research into mainstream clinical therapies is making significant progress, as a large number of cell-based clinical studies are currently underway - some 2,700 stem cell clinical trials registered with www.clinicaltrials.gov between February 2000 and June 2010. While several companies have launched stem cell products onto the market, it’s the number of products in the pipeline that is starting to capture the attention of observers – including investors – who believe activity in current clinical trials is a telling sign of where the industry is headed.

Fractional Flow Reserve Makes Inroads In Interventional Cardiology

curtwerner@comcast.net — Fri, 27 Jan 2012 03:00:00 -0500

Fractional flow reserve (FFR), a measurement of the severity of a coronary artery obstruction, has not yet reached mainstream use in the US, but that could soon change as interventional cardiologists face increased scrutiny about the “appropriateness” of their clinical treatment decisions. Part of that scrutiny will be driven by recent overstenting scandals, but cost-control measures are playing just much of a role in this shift.

New Horizons In Medical Imaging: An Interview With Siemens’ Gregory Sorensen

a.staylor@elsevier.com — Fri, 27 Jan 2012 01:00:00 -0500

Marketplace uncertainty and pressures to reduce costs have had a major impact on the market for medical imaging technologies. Medtech Insight interviews Gregory Sorensen, MD, Siemens Healthcare’s CEO for North America about what’s on the horizon for the industry.

Abiomed Touts Advantages Of New Symphony Partial-Support Cardiac Assist Device

curtwerner@comcast.net — Fri, 27 Jan 2012 00:00:00 -0500

Since heart attacks most often damage the left ventricle, left ventricular assist devices (LVADs) have become the treatment of choice for end-stage heart failure (HF) patients in this country. But pure product prices for today’s LVADs, which had previously been relegated to use only in end-stage disease but now are moving towards the treatment of earlier-stage HF patients, run as high as $120,000 per unit.

Market & Industry Briefs

m.thompson@elsevier.com — Fri, 27 Jan 2012 00:00:00 -0500

Brief summaries of recent medtech market and industry developments.

Deals Update

b.detuzzi@elsevier.com — Fri, 27 Jan 2012 00:00:00 -0500

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

Washington Roundup

m.thompson@elsevier.com — Fri, 27 Jan 2012 00:00:00 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover new FDA guidance on manufacturers’ responses to unsolicited requests for off-label information, and FDA’s de novo draft guidance.

Start-Up News

tracyneilssien@yahoo.com — Fri, 27 Jan 2012 00:00:00 -0500

Noteworthy news from medtech start-ups. This month we profile Ibris, which is developing prognostics to identify breast cancer patients in need of chemotherapy, and Delphinus Medical Technologies, whose platform enables 3-D full breast ultrasound.

IN3 Medical Device 360° 2012 – Orlando

Fri, 27 Jan 2012 00:00:00 -0500

Publisher’s Spotlight: Register today for The Investment in Innovation (IN³) Medical Device 360° Conference, being held February 29-March 2, 2012, at the Ritz-Carlton Orlando, Grande Lakes and take your company to the next level.

A Bright Future For Optical Imaging

a.staylor@elsevier.com — Fri, 16 Dec 2011 00:00:00 -0500

One bright spot emerging in this otherwise lackluster economy is the market for optical imaging technologies. Optical imaging encompasses a wide array of current and emerging techniques that use light as the primary imaging modality to characterize local anatomy down to cellular and molecular levels.

As TAVI Advances, Adjunctive Devices Multiply

m.thompson@elsevier.com — Fri, 16 Dec 2011 00:00:00 -0500

As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need.

Facial Aesthetics Market: New Technologies Address Consumer Demand

r.neil@elsevier.com — Fri, 16 Dec 2011 00:00:00 -0500

Consumers of aesthetic procedures are still looking for the perfect option – one that produces a more youthful looking face, but does not require much, if any, downtime. Ideally, these consumers also would like something that offered a long-lasting effect and was delivered with minimal pain and discomfort.

The Ins And Outs Of The Aesthetics Market: An Interview With Steven H. Dayan, MD

r.neil@elsevier.com — Fri, 16 Dec 2011 00:00:00 -0500

The effectiveness of a product is only one aspect of how well a device will succeed in the aesthetics market. In the following interview, Steven H.

Laser Cataract Surgery: Sorting Out The Business Case

Michael@LachmanConsulting.com — Fri, 16 Dec 2011 00:00:00 -0500

The once staid US cataract surgery market has evolved considerably over the past several years. A trio of conferences this fall provided updates on the latest developments.

Knee OA: Growing Demand For Nonsurgical Options

sharon@biomedgps.com — Fri, 16 Dec 2011 00:00:00 -0500

The knee replacement market is posting flat growth across the board as more patients seek nonsurgical options to manage their pain. Although such treatments typically last only a few months, many patients willingly accept the durability tradeoff to avoid the cost and downtime associated with surgery.