Medical Devices Today

Agencies Launch White House-Mandated Review Of Regulations

Article preview from "The Gray Sheet"- May 30, 2011

FDA and CMS announced preliminary plans May 26 for updating, streamlining or eliminating certain regulations in response to a White House request.The targeted rules include a collection of device-specific initiatives, although many of the efforts pre-date the Obama administration initiative.

Trends in the Cath Lab: FFR Emerging as Stenting Gatekeeper

Article preview from Medtech Insight - April  01, 2011

Clinical advancements in the cardiac catheterization lab most often occur in fits and starts, rarely in smooth progressions. Momentous developments like the percutaneous transluminal coronary angioplasty catheter, the bare metal stent, and then the drug-eluting stent shook both the profession and the industry.

Altura Medical Inc.

Article preview from Start-Up - April  01, 2011

Altura Medical is developing a percutaneous, low-profile endovascular stent-graft for the treatment of AAAs designed to eliminate some of the major issues associated with conventional endograft procedure safety, efficacy and complexity. The company's plan is to provide a flexible, off-the-shelf, ultra-low profile device with an industry-first 12 French inside diameter. The Altura system may be placed routinely in the cath lab as an outpatient procedure, and in more difficult AAA anatomies that are usually referred for open surgery, including those patients with short necks or smaller, tortuous iliac arteries.

The New World Of Device Venture Investing: Same As The Old World?

Article preview from IN VIVO - April 01, 2011

At Elsevier Business Intelligence's February IN3 West conference, a panel of leading device venture investors, who remain committed to and are actively doing deals in medtech, discussed how the recent recession has affected device investing and how much, if at all, that world has changed as a result.

Cardiologist Group Calls For Centralized Device Oversight In Europe

Article preview from "The Gray Sheet"- May 23, 2011

The European Society of Cardiology says medical device oversight in Europe is not sufficient, and is calling for a single European regulatory body to oversee product evaluation and approval.

Provider Trends: ACOs Begin to Take Shape

Article preview from Medtech Insight - April  01, 2011

A new health-care delivery mode that could drastically alter how the industry is run took another significant step forward at the end of March, when the US Department of Health and Human Services issued proposed rules to govern Accountable Care Organizations. ACOs are designed to create strong networks of physicians and hospitals with aligned incentives focused on patient quality of care and costs. To gain some insight on possible future implications of ACOs for the medical device industry, Medtech Insight recently spoke with Ron Wince, president and CEO of the consulting firm Guidon Performance Solutions.

Is Therapeutic Hypothermia Finally Heating Up?

Article preview from Start-Up - April  01, 2011

Therapeutic hypothermia companies have largely been disappointing for investors who poured in -- and lost -- fortunes investing in promising cooling technologies. But while many first-generation start-ups no longer exist, the technologies they developed live on within the large corporations that paid pennies on the dollars to acquire them. Although the pioneers in the field failed to meet their objectives, there is reason for hope.

PEAK Cuts Into The Competitive Electrosurgery Market

Article preview from IN VIVO - April 01, 2011

PEAK Surgical is looking to crack the OR market with its PlasmaBlade, which uses RF energy to dissect and seal tissue. But to get there it will have to go head-to-head with some of the device industry's giants.

FDA Mulling Higher User Fees For Bundled Submissions

Article preview from "The Gray Sheet"- May 16, 2011

FDA is considering increasing user fees or lengthening the review performance goals for pre-market submissions that bundle multiple devices into a single application.

EVAR Market: Challenges, Innovation and Growth

Article preview from Medtech Insight - April  01, 2011

Endovascular aortic aneurysm repair procedures account for the majority of abdominal aortic aneurysm repairs performed in the US, and total worldwide revenues from aortic endograft systems now exceed $1 billion per year. Many believe that continuing improvements in endograft technology will drive EVAR penetration to 90% or beyond within the next five to 10 years. However, before that milestone is reached, the field must address a number of lingering concerns about long-term endograft stability and viability, and endograft systems will need to evolve to encompass a wider range of patients with challenging anatomy, including small or tortuous access vessels, short or highly angulated aortic necks, and aneurysms that lie close to the renal arteries.