Good news, bad news for Cook stent business
While Bloomington-based medical-device maker won approval for new bile duct stent, it has recalled its hot-selling arterial stent from all global markets.
While Bloomington-based medical-device maker won approval for new bile duct stent, it has recalled its hot-selling arterial stent from all global markets.
Bloomington-based Cook Medical won approval for the first drug-coated stent for clogged leg arteries in the United States, which accounts for 40 percent of the soon-to-be $3 billion market.
The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg.
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014.
A drug-coated stent from Indiana-based Cook Medical was more effective than standard therapy for patients with blockages in an upper-leg artery, a study found.
Bloomington-based Cook Medical has won European approval for a new artery-opening device for the legs that it predicts will
be a blockbuster.
Cook Inc. plans to slide its coated-stent ambitions from the heart down to another region of the body where a multimillion-dollar market awaits. The Bloomington-based medical-device maker recently started testing a product that uses the same drug Cook put on a coronary stent it tried to develop a couple of years ago with Guidant Corp. Instead of treating arteries near the heart, the Zilver PTX stent targets blockages in the major artery that runs through the thigh. Cook is the…
Indianapolis-based Eli Lilly and Co., already the promoter of the leading anti-impotence pill Cialis, will now try to speed up development of a drug to treat premature ejaculation. Canada-based TVM Life Sciences Ventures VII, which manages funds supplied by Lilly, invested in Ixchelsis Ltd., a new company created in the United Kingdom to develop the experimental drug, which is called IX-01. The drug was originally discovered at a research facility in the United Kingdom operated by New York-based Pfizer Inc., the company that brought the anti-impotence pill Viagra to market. Lilly’s Chorus unit will oversee development of the drug to determine if its proposed concept of action appears to work. “TVM’s strategic relationship with Lilly enables its project-focused companies, like Ixchelsis, to reach clinical proof of concept efficiently and cost-effectively,” said Darren Carroll, Lilly’s vice president of corporate business development, in a prepared statement. If and when the drug’s proof-of-concept is verified, Lilly will have the option to acquire the drug for further development. Lilly and TVM estimate that as many as 30 percent of men worldwide suffer from premature ejaculation.
Warsaw-based Zimmer Holdings Inc., which lost a February trial against Stryker Corp. over a surgical device, was told to pay more than $228 million—three times the jury award plus other costs—and stop selling certain products. According to Bloomberg News, the increase in the jury award was appropriate because Zimmer intentionally infringed Stryker patents to build its business for pulsed lavage, a technique that removes damaged tissue and cleans bones during joint-replacement surgery, U.S. District Judge Robert Jonker said in an order issued Wednesday. He also ordered Zimmer to stop selling its Pulsavac Plus device. A federal jury in Grand Rapids, Mich., in February sided with Stryker and awarded $70 million in damages. The dispute is over devices that use pulsing liquid, such as water or saline solution, to loosen debris from a surgical site and remove it by suction. The $228 million figure is more than the second-quarter profit for either company. Kalamazoo, Mich.-based Stryker reported $213 million in earnings on sales of $2.2 billion. Zimmer, based in Warsaw, reported $152 million in earnings on $1.2 billion in sales.
Three months after the recall of its Zilver PTX stent to prop open peripheral arteries, Bloomington-based Cook Medical Inc. put the device back on the market around the globe, according to MassDevice.com, an industry trade publication. Cook voluntarily recalled the stents in April after getting reports of one patient death and one injury when the equipment that delivers the stent into patients broke off during surgery. In late May, the U.S. Food and Drug Administration slapped its “deadly” warning on Cook’s recall of its stent, which props open arteries in the legs and arms to prevent serious blood clots. Millenium Research Group has estimated that Cook derives $2,750 from each Zilver stent it sells in the United States. Since it first hit foreign markets in 2009, the Zilver stent has been deployed in more than 30,000 patients, according to data from Cook. The Zilver, which is the first stent covered with an inflammation-reducing drug, was introduced to the U.S. market in December 2012. The Zilver recall did not affect stents that were already placed in patients.
Franciscan St. Francis Health entered an exclusive-provider agreement with Greenwood-based Indiana Internal Medicine Consultants, one of the largest physician groups working at Franciscan’s hospitals. The practice has 37 doctors specializing in family practice, internal medicine, infectious disease and sleep medicine. The tighter relationship, which took effect Oct. 1, is designed to help Franciscan function as an accountable care organization. That concept, promoted in the 2010 health reform law, calls for hospitals and doctors to work together to care for a specific population of patients—and have some of their pay hinge on how well they maintain the health of that population. Hospitals around Indianapolis and the nation have been acquiring physician practices or entering tight contractual relationships, such as Franciscan’s exclusive-provider agreement, which will not allow Indiana Internal Medicine’s doctors to practice at hospitals outside the Franciscan chain. Franciscan operates hospitals in Beech Grove, Indianapolis and Mooresville.
The pain isn’t ending for the Warsaw-based makers of orthopedic implants. Democrats from the House Energy and Commerce Committee have asked Republican leaders to hold hearings on metal-on-metal hips, saying they have caused "significant harm to human health". The FDA is conducting its own review of metal-on-metal, having requested post-market data from about 20 companies, including Warsaw-based DePuy Orthopaedics, Zimmer and Biomet, as well as New Jersey-based Johnson & Johnson.
Bloomington-based Cook Medical Inc.’s drug-coated stent to treat blocked femoral arteries is sailing toward approval. The Zilver PTX got an 11-0 approval vote from a panel of outside advisers to the U.S. Food and Drug Administration, according to Bloomberg News. The FDA does not have to follow the recommendations of its advisory panels, but it usually does. The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. It would be an alternative to bypass surgery, angioplasty or the use of a stent without a coating of a drug, paclitaxel, which is designed to reduce the build-up of new fatty deposits. Peripheral arterial disease affects 8 million to 12 million people in the U.S., according to the Peripheral Arterial Disease Coalition, and can lead to heart attacks and strokes.