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Wednesday, October 29, 2008

Cyberonics Takes Center Stage

Selecting the Manufacturer of the Year is always tough. After reviewing many worthy nominations from our readers, though, one medical device company rose to the top—Cyberonics. The medical device company stood out because it showed a rare combination of market success, outstanding innovation, and an ability to overcoming adversity with strategic vision.

The device firm is one of the few that focus on the neuromodulation and neurostimulation field. Despite the company’s setbacks last year, its technology platform has much potential. Neuromodulation is often compared with cardiac rhythm management (CRM) technology and is expected to revolutionize treatment of the brain in much the same way CRM did the heart.

Cyberonics’s technology—VNS Therapy—delivers stimulation via a device implanted just under the skin in the left chest area. It is unlike its competitors. The device sends mild, intermittent electrical impulses through a lead to the left vagus nerve, which then sends signals to the brain.

The company also overcame a series of challenges. After spreading itself too thin among a variety of potential applications, Cyberonics is moving forward with a renewed focus on growing the epilepsy application of its VNS Therapy. Its quick, unexpected turnaround and the contributions its technology has made to healthcare made the firm an obvious choice for the honor.

MD&DI has also highlighted two other outstanding OEMS—Abbott Laboratories and Volcano Corp.—whose accomplishments are worth noting. Abbott Labs has made some great strides, especially considering the recent concerns about drug-eluting stents (DES). Within three months of earning FDA approval, the company’s next-generation Xience V stent became a market leader. In addition, the company has continued to see significant overall growth.

Another success story is Volcano. Its intravascular ultrasound (IVUS) platform centers on a catheter-based system that enables physicians to examine diseased vessels from inside the artery. Volcano is helping physicians understand how to better treat the disease and to make sure that the treatment is taking place at the right location. The company says its technology means that the procedures are faster and the systems are easier to use, which has led to a twofold increase in the use of its product.

Whatever the reason for their success, these companies each represent the innovation and value that medical device firms bring to patients worldwide.
 

Sherrie Conroy
sherrie.conroy@cancom.com 
  




Manufacturer of the Year
The Rise of Cyberonics

By Erik Swain
After battling underperformance and bad publicity, Cyberonics regains its footing.

Web Exclusive! Read about two other outstanding OEMs:


Orthopedics Design
Making It Personal
By Andy Christensen and David Chen
Changes in the industry landscape have made it easier for orthopedic manufacturers to create personalized implants.


Software
Setting the Stage for Electronic MDRs
By Peter Hyman
Ready or not, industry must prepare for electronic regulatory systems.


Offshoring
All Eyes on India
By Ames Gross and Momoko Hirose
As the industry becomes increasingly regulated in India, device manufacturers may want to explore whether to set up facilities there.


 More from this issue of MD&DI  

 


Escaping Warning Letter Blues

Warning letters typically mean bad news. But the data can provide an informative look at patterns in the industry.



 

 

 
Prosthetic Vein Valve Goes with the Flow
The device may replace nonfunctioning valves in patients suffering from chronic venous insufficiency, a condition that occurs when veins can’t pump blood back to the heart.
  



Human Factors: A New Standard Coming Soon
The upcoming release of AAMI HE75 should be of great help to device manufacturers. The standard is an encyclopedic document containing more than a thousand human factors guidelines for the design of safe, effective, and user-friendly medical devices.
  



Critics Question CDRH's Moves on LASIK
The center seems to have heightened its censorship and nondisclosure on LASIK devices.

 


 

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