Medical Devices Today

Unapproved Product Trial Data: To Post Or Not To Post On ClinicalTrials.gov?

Full article reprinted from "The Gray Sheet" - June 29, 2009

Device makers say new clinical trial registration and results reporting requirements should be extended to trials of unapproved products only if the trials were stopped for safety reasons. Read more...

FDA Expects Draft Document On Post-Approval Study Design By September

Full article reprinted from "The Gray Sheet" - June 29, 2009

FDA hopes to complete a draft scientific document on how to design post-approval studies for medical devices by September, according to Danica Marinac-Dabic, director of the Division of Epidemiology within CDRH's Office of Surveillance and Biometrics. Read More...

Greater FDA Transparency Could Benefit Industry, Too, Trade Reps Say

Full article reprinted from "The Gray Sheet" - June 29, 2009

Despite concerns with maintaining trade secret protections, industry has much to gain from increased openness by FDA, device industry representatives said at a June 24 meeting of FDA's new Transparency Task Force. Read more...

Boston Scientific Changes CEO/President Job: Elliott For Tobin

• Boston Scientific Changes CEO/President Job: Elliott For Tobin
• Medtronic, Other Large Device Makers Pressured By Health-Reform Move
• Boston Scientific To Invest Nearly $130 Million In Ireland Plant
• Medtronic, MiniMed Get FDA Warnings About Handling Pump Problems
• Baxter Buys Edwards Lifesciences Dialysis Unit For $65 Million
• Siemens AG CEO Defends Use Of Medical-Imaging In Health Care

Market in Focus: Surgical Sealants and Glues

Article preview reprinted Medtech Insight - May, 2009 

Over the past few decades, the wound closure market has seen the introduction of a number of new technologies, including a variety of surgical adhesives and glues for both external and internal use to hold tissues together and/or reinforce surgical suture or staple lines. These products address a market that encompasses over 73 million surgical wounds annually in the US alone and generated sales of over $367 million in the US last year, according to Medtech Insight's recently published report US Markets for Current and Emerging Wound Closure Technologies. The US market for surgical sealants and glues is growing at an annual rate of about 3.8% and is expected to reach about $443 million in sales by 2013. Read more...

Medtronic, Smith & Nephew, Stryker Paid Six Figures To U. Wis. Profs

• Medtronic’s MRI-Safe Pacemaker Gets EU Clearance
• Medtronic, Smith & Nephew, Stryker Paid Six Figures To U. Wis. Profs
• Zimmer, Smith & Nephew, J&J, Stryker Buoyed By New-Knee Study
• Stryker’s Joint Devices Seen Driving Economic Rebound
• Abbott’s Xience Prime Drug-Eluting Stent Wins European Approval
• Boston Scientific Trial Shows Early Success Of Heart-Device Combo
• Medtronic Gets Federal Subpoena Over Financial Ties To Accused Doctor

FDA Struggles To Create A User-Friendly Device Identification System

Full article reprinted from "The Gray Sheet" - June 22, 2009

The hardest part about establishing a mandatory unique identification system for devices is crafting one that all users - from manufacturers to distributors to hospitals - will be able to implement, FDA says. Read more...

Synthes Charged With Unauthorized Spine Repair Trial, Faces $34 Mil. Fine

Full article reprinted from "The Gray Sheet" - June 22, 2009

Orthopedic device maker Synthes and its Norian subsidiary face $34.8 million in potential fines for allegedly skirting FDA requirements and conducting unauthorized clinical trials of their Norian XR and Norian SRS bone cement for vertebral compression fractures. Read more...

Congress, FDA Commissioner Question Device Pre-Market Review Process

Full article reprinted from "The Gray Sheet" - June 22, 2009

House Energy and Commerce Health Subcommittee Chair Frank Pallone said legislation is needed to restrict the types of devices cleared through FDA's 510(k) process. Read more...

Comparative Effectiveness and the Medical Device Industry

 
An exclusive Q&A with Bill Sarraille, Senior Partner with Sidley’s Health Care Practice.

 
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Bill Sarraille discusses the widespread concerns regarding comparative effectiveness and its potential impact on the medical device industry. According to Sarraille, "We’re going to be in a situation where companies will have to think long and hard about the strategic and tactical decisions around what kind of research to do and how to do it, because in an age where there is transparency about clinical trial research, the reality is that the kinds of research that companies will be doing from a comparative effectiveness perspective will be very public." He added, "If companies don’t conduct comparative effectiveness research in a careful way, a thoughtful way, it’s quite possible that they could develop evidence that would be very contrary to their interests."

Bill Sarraille shared his insights with Medical Devices Today about:

• The new challenges comparative effectiveness are likely to create for the medical device industry, including some pitfalls to be on the lookout for.
• The risks that comparative effectiveness will create for the health care industry as a whole.
• The international implications of comparative effectiveness and the lessons we have already learned about it from its use in Europe and Great Britain.

• Click here to download the exclusive 6-page Q&A with Bill Sarraille