Boston Scientific said it will appeal a $700 million verdict against it after a United States District Court judge in Delaware found that it had violated a Johnson & Johnson patent covering stent technology. The suit, originally filed in 1997, concerned Boston Scientific’s NIR stent, which it hasn’t sold since 2004. Last month, the court denied Boston Scientific’s motion for a new trial and approved J&J’s motion for entry of judgment. The decision awarded J&J about $400 million in damages and about $300 million in interest.
– From DeviceTalk.
A study conducted by Duke University researchers has concluded that a total knee replacement provides greater mobility and independence–and there’s no age limit to reaping those benefits. Published in the October issue of Arthritis & Rheumatism, the study found that older patients who had knee replacements were twice as likely to show improved mobility versus those who didn’t have the procedure (In addition, those who didn’t have the surgery also saw a decline in physical function). While doctors are sometimes more hesitant to recommend the procedure in older patients, this new evidence could help change their point of view and give them more confidence in suggesting the surgery for anyone who is a candidate, regardless of age. The study, funded by InHealth, also pointed to the cost efficiency of knee replacements, which the Agency for Healthcare Research and Quality placed at averaging between $4,000 and $6,000. The savings related to a year of free of disability is about $50,000, according to the National Bureau of Economic Research.
Appropriately named Hercules, a three-stage balloon dilator launched by Cook Medical is made using proprietary technology (P.E.T.FLEX) that the company says is the strongest dilation material available. It combines high tensile strength and the flexibility needed for a balloon that inflates to three distinct and increasing diameters. Hercules is designed for use in benign and malignant esophageal strictures–the narrowing of the esophagus that causes difficulty or painful swallowing, and food regurgitation. The balloon is inflated in the esophagus to open these strictures. One of the advantages of P.E.T.FLEX is that it keeps its shape and strength during dilation, and studies have shown that the balloon produces 154% greater radial force than its competition. This could reduce the need for a repeat procedure. Hercules is used with a Rapid Deflation Sleeve and an express evacuation catheter, which quickly deflates the balloon upon the application of negative pressure to the inflation device.
The Wall Street Journal has obtained an unredacted version of a 2002 lawsuit against Medtronic that contains some very damning allegations about practices of its spinal division — and was brought by a former lawyer for the firm, Ami Kelley. It states that the company gave spinal surgeons “a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska, and patent royalties on inventions they played no part in.” The lawsuit, brought to recoup Medicare-fraud-related damages for the government, was one of two that led to Medtronic’s $40 million settlement with the government in 2006. Kelley said she was fired by Medtronic after questioning the payments.
That settlement may now be in jeopardy, as the other lawsuit’s plaintiff, Jacqueline Poteet, has appealed the dismissal of her suit, saying the settlement was too small. Whistleblowers who help the government recover money can share in the settlement. If an appeals court reverses the dismissal, the government and Medtronic both have the right to void the settlement.
Medtronic said it drastically revamped its policies regarding payments to physicians in 2004.
Boston Scientific announced that it has received FDA approval for the Taxus Express2 Atom drug-eluting stent system, which is the first drug-eluting stent designed for small coronary vessels. It is the first DES approved by FDA for use in vessels as small as 2.25 mm in diameter. The firm also got approval for the Taxus Express2 DES, which is indicated for treatment of in-stent restenosis in bare-metal stents.
This gives Boston Scientific four DES models on the U.S. market, the most of any company. The other two are the original version of Taxus and Promus, the firm’s version of Abbott’s Xience V, originally developed by Guidant.
UPDATE: Boston Scientific CEO Jim Tobin says he expects FDA approval of Taxus Liberte, the firm’s next-generation DES, to come by the end of the year at the latest. The Express approvals are also a sign that FDA is gradually lifting the “corporate warning letter” it levied against the firm in 2006, which had prevented it from introducing certain products.
Applied Data Research has come out with a report on the market for wireless cardiovascular implants, a market it expects to grow because it is a “new phase in the marriage of electronics and medical devices – one in which critical patient data can be used be caregivers to modify treatment protocols or schedule interventional procedures in response to current patient status regardless of the patient’s location.” It envisions that the growing demand for this technology will increase the importance of service centers or specialized service bureaus that function by relaying device data to the appropriate respondent. The full report can be purchased for $1850.
DePuy Spine Inc. and Biedermann Motech GmbH are settling a patent lawsuit against Allez Spine in which the two companies accused Allez’s Laguna screw products of infringing on a patent. As part of the settlement, Allez will make a payment for an undisclosed amount to DePuy and Biedermann. They also granted Allez a license under the patent of interest to continue making, using, and selling the Laguna screw products. Allez will have to pay a royalty on sales of the Laguna system as well.
FDA has approved a knee system made by De Puy Orthopaedics Inc. that is supposed to increase flexion of the joint. The LCS Complete RPS Flexion Knee aims to meet the needs of patients who have a more active and demanding lifestyle.
Two studies published in the New England Journal of Medicine indicate that arthroscopic knee surgery is performed more often than it needs to be, particularly on arthritis patients, reports the Associated Press. One found that surgery worked no better than medication and physical therapy in regards to relieving pain and stiffness from moderate or severe arthritis. Another found that tears in knee cartilage, which often prompt the decision to have the surgery, often do not cause symptoms. Two-thirds of study participants who had knee cartilage tears reported no pain or stiffness in the prior month.
The authors said the procedure can benefit those with large tears, recent injuries, or milder symptoms. But it should not be performed routinely on osteoarthritis patients. During the procedure, a scope with a miniature camera is inserted through a tiny incision and surgeons operate through other tiny cuts. Surgeons typically smooth damaged cartilage surfaces on the bone’s ends and flush out bone chips.
Some speculate that the increased use of MRI has led to more diagnoses of knee problems, which has led to more arthroscopic surgeries, some of them being unnecessary.
– From DeviceTalk.
Zimmer Holdings has announced its plans to buy Abbott Laboratories’ spine division. The $360-million deal should be completed by this year’s fourth quarter. Zimmer’s spine business reached $197 million in sales last year, only five percent of its total sales. Abbott Spine hit $109 million in 2007, which is a very small portion of its total drug and device sales revenue of $25.9 billion. David Dvorak, Zimmer’s CEO, said the acquisition will strengthen the company’s sales scope, product pipeline, and add to its R&D capabilities.
–From DeviceTalk
