Top Device Companies

Zimmer, Stryker Most Affected By 510(k) Changes, St. Jude, Edwards Less

Zimmer Holdings, Stryker and similar device makers of innovative products not as complex as heart devices have the most to lose later this year when the FDA begins changing its 510(k) approval process. The head of the Center For Devices and Radiological Health attempted in an interview to settle some of the confusion surrounding vows to strengthen regulations. Director Jeffrey Shuren said an agency report on the subject would be issued in a few weeks to clarify the 510(k) updating process, adding some changes would precede the Institute of Medicine’s own report on the issue set for the middle of next year. St. Jude Medical, Edward Lifesciences and other makers of complex heart devices already face tougher reviews of their devices and would be less-affected by 510(k) changes. (Click here for more – a subscription may be required)

“FDA Devices Chief Aims For Clarity Soon On Potential Changes” – Wall Street Journal (7/6/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Medtronic Gets U.K. Appeals Court Win In Edwards Valve Patent Suit

Medtronic won an appeal in a U.K. court when a three-judge panel reversed an infringement case brought by Edwards Lifesciences. The dispute involved artificial heart-valve technology used in devices made for each of the U.S.-based companies and marketed in the United Kingdom.Medtronic’s CoreValve’s catheters enabling valve replacement was said to infringe on Edward’s patent in both countries for its Sapien heart valves. A U.S. court awarded Edwards $73 million in a similar suit, but a German court ruled similarly to the U.K. court. (Click here for more)

“Medtronic Wins U.K. Appeal Over Edwards Valve Patent” – Bloomberg (6/30/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Edwards Expects Major Sales From Sapien Now In U.S. Testing Phase

Edwards Lifesciences is developing a heart valve its CEO believes could change the medical-device industry. Michael Mussallem said the Sapien valve, still in trials, could enter the U.S. market as early as late next year to lead one of the biggest recent advances in heart valves. Sapien is inserted through a catheter to the heart, obviating the need for major surgery. The device already is on the market in Europe where sales may seem modest, but are unexpectedly large to Mussallem, who cites the continent’s usually slow acceptance of new devices. (Click here for more)

“Promise Of New Valve Driving Edwards” – Orange County Business Journal (5/16/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Edwards Warned By FDA Over Six Device-Reporting Failures

Edwards Lifesciences received a warning from the FDA, saying it was late in reporting issues in at least six instances related to its devices. Edwards said it already has corrected training procedures for reporting to the agency. The firm said it does not expect the matter to affect its approval applications. The FDA sent the letter following an inspection of one of the company’s sites last September. (Click here for more)

“FDA Sends Warning Letter To Edwards Lifesciences” – Forbes (AP) (4/6/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Medtronic To Pay Edwards $74 Million In Patent Case, Face Millions More

Medtronic lost a $74 million suit brought by Edwards Lifesciences for infringing on patents for heart valves. A federal court jury found Medtronic willfully infringed on Edwards’s patents by producing the CoreValve competitor. Because the jury found the infringement to be intentional, Medtronic could face an additional $222 million in damages. Medtronic said it would appeal the decision. CoreValve was found in British and German courts not to infringe on the Edwards patents. (Click here for more)

"Edwards Wins $74 Million In Heart Valve Patent Case” – Orange County Business Journal (4/2/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Medtronic, Edwards Heart Valves Said To Have Long-Term Demand

Medtronic and Edwards Lifesciences have won the plaudits of an analyst for their less-invasive heart valves. The analyst said several meetings with physicians convinced him the valves have a potential for long-term growth. He said Medtronic’s CoreValve and Edwards’ Sapien are praised by cardiologists who view the devices as the next significant market in cardiology. The valves have European Union clearance, but Edwards expects U.S. approval later this year, while Medtronic is not expected to be ready until a few years from now. Both firms could face competition from Abbott Laboratories and St. Jude Medical, which are developing their own versions. (Click here for more)

“Analyst: Doctors ‘Encouraged’ By New Heart Valves” – Orange County Business Journal (3/8/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Optics Subsidiary Head Named New Chairman Of AdvaMed

Abbott Medical Optics Chairman James Mazzo has agreed to serve as chairman of the Advanced Medical Technology Association the next two years. The trade group represents the medical device industry. Mazzo replaces Mike Mussallem, CEO of Edwards Lifesciences. Abbott Medical Optics was bought by Abbott Laboratories last year while Mazzo was CEO of the unit. (Click here for more)

“Abbott Executive To Chair Medical Device Lobby” – CNBC (AP) 3/4/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Edwards Wins German Court Ruling On Patent For Heart Valve

Edwards Lifesciences was the winner in Germany when a court ruled its transcatheter heart valve technology was properly protected by a patent. Edwards had sued Medtronic’s CoreValve two years ago, alleging patent infringement. CoreValve countered the patent was not valid and pressed the matter in court. Germany’s Federal Patent Court ruled the Edwards patent was valid, leading to the suit against CoreValve. (Click here for more)

“Edwards Lifesciences Wins German Patent Appeal” – New York Times (AP) (1/19/10)

JUST PUBLISHED: Medical Device Market 2009: Interventional Cardiology - Find out who’s going beyond catheters and drug-eluting stents in this vibrant space with this 86-page Special Report previously published in IN VIVO: The Business & Medicine Report. Order yours now!

Edwards Heart-Valve Ring At Center Of FDA, Physician Disputes

Edwards Lifesciences is involved in a dispute involving medical ethics and the FDA’s approval process. The device involved is the Myxo heart-valve ring, which Edwards makes without specific FDA approval because the maker believes it is too much like another, approved heart-valve ring it makes. Two Northwestern University physicians are arguing over authorship of the ring, one of whom implanted the device in more than 150 patients before formal FDA approval.
One physician said the other experimented on patients without their approval, leading the agency to review its approval procedures. (Click here for more – a subscription may be required)

“Doctors’ Spat Exposes FDA Loophole” – Wall Street Journal (12/29/09)

JUST PUBLISHED: Medical Device Market 2009: Interventional Cardiology - Find out who’s going beyond catheters and drug-eluting stents in this vibrant space with this 86-page Special Report previously published in IN VIVO: The Business & Medicine Report. Order yours now!

Medtronic Chases Edwards Leadership In Transcatheter Heart Valves

Medtronic and Edwards Lifesciences transcatheter heart valves are fast-becoming common devices in the medical field, with promises of attracting healthier patients as well as ill ones. Medtronic moved into the field in a major way when it paid $1 billion to buy a pair of small firms developing the technology. Medtronic’s move was intended in part to enable it to compete with Edwards’ leadership in the field. (Click here for more)

“The Ever-Evolving Heart Valve” – St. Paul Pioneer Press (11/20/09)

JUST PUBLISHED: Medical Device Market 2009: Interventional Cardiology - Find out who’s going beyond catheters and drug-eluting stents in this vibrant space with this 86-page Special Report previously published in IN VIVO: The Business & Medicine Report. Order yours now!