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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.
–From Precision Talk

Cardinal Health’s grand experiment is over. The conglomerate, one of the largest distributors of drugs and other products to hospitals, attempted in recent years to become a medical device company also. But now it has decided to spin off its high-margin, high-tech medical device businesses, reports Reuters. It is doing so in order to focus on turning around its core drug distribution business, which has been underperforming. The spinoff is expected to be completed by the middle of next year.

The new company’s product lines will include Alaris drug infusion pumps, ATEA and LTV respiratory ventilators, and Pyxis automated drug dispensing systems for hospital pharmacies. These high-margin, attractive products could help the new company get a more favorable stock valuation on its own than as part of Cardinal. Cardinal will retain lower-margin and commodity medical products such as surgical gloves and fluid management systems.

David Schlotterbeck, who heads the division of Cardinal that includes the businesses being spun off, will be the CEO of the new company, which will be based in San Diego.

Covidien, the life sciences conglomerate with a significant portion of its business in medical devices, announced that it will begin a restructuring program in fiscal year 2009. It did not provide details other than to say that it will take a charge of $200 million in restucturing costs at the beginning of FY ‘09, and that it expects the program to save between $50 million and $75 million per year in operating costs. That suggests job cuts are coming.

The goal is to “improve cost structure and to deliver improved operating growth.” CEO Richard J. Meelia said the restructuring should enable the company to invest more in R&D, and to expand into other product areas.

Medtronic announced plans to purchase a Canadian firm that makes a device to treat atrial fibrillation for $380 million, the Star Tribune of Minneapolis reports. The deal for CryoCath Technologies Inc. is expected to close by the end of the year. CryoCath’s signature product is Arctic Front, a minimally invasive cryo-balloon catheter that may be a safer alternative to current treatments, which include drugs and electrical shocks to the heart. It has received approval in Europe but not yet in the United States, where a pivotal trial is in progress. Some are surprised that Medtronic acted now instead of waiting for the results of the trial, but if it were successful, the firm’s price could have gone up. And Medtronic rival St. Jude Medical has already bought up several players in this space.

The Wall Street Journal has obtained an unredacted version of a 2002 lawsuit against Medtronic that contains some very damning allegations — 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 the firm’s next-generation DES, Taxus Liberte, to come by the end of the year at the latest. The Express approvals are a sign that FDA is gradually lifting the “corporate warning letter” it levied against Boston Scientific in 2006, which had prevented the firm from introducing certain products.

– From PrecisionTalk.

By now, most device companies probably know this. What they also should know is that delivering products internationally takes careful preparation and research from the start. Take Covidien, for example. After its first year as an independent company, it reported nearly $9 billion in revenue for 2007. What’s the company’s strategy? Joe Almeida, president of Covidien’s medical device business, told MD&DI some of the company’s key tactics for global product development: understanding the marketplace in which it’s embarking, listening to the voice of the customer, and looking at how to innovate with the most compelling outcome. “It’s not just about being the first to market, but being the right to market,” Almeida told us as AdvaMed 2008. It’s also not about how many products a company launches in a year, but how they fit into the space.

Almeida also spoke on a panel about risk, innovation, and globalization during the event. He has a strong opinion about bringing customer input into the equation. It’s important to reach out from every single location point, or you run the risk of failing to identify the global need. Having feet on the ground (literally) in locations of interest will help companies understand local issues, and be strategic about where you place employees within those countries, advised Johnson & Johnson’s Richard Toselli, MD, another panel speaker. Toselli is the vice president of evidence-based medicine at J&J’s Office of Science and Technology.

While Almeida says companies should strive to reach countries outside of their comfort zone, they must clearly understand the regulations. From there, the risks that manufacturers take will be based on how well they know the market.

Access and affordability are other key issues for product launches in emerging markets. Stakeholder economics are much different outside of the U.S., said Toselli. In some countries, it’s harder for workers to take a lot of time off to recover from surgery, which means a need for more minimally invasive products. But it’s not just as simple as providing this solution. Companies need to look at the reimbursement situation surrounding those products and advanced planning is an essential part of this process. Since this differs depending on the region, understanding evidence requirements before trying to introduce devices in crucial. In the end, it’s all about outcomes that a product has on the patient, the physician, and the provider, according to Almeida. So when it comes to evidence-based medicine–”If you don’t have it, you’re not playing in this game anymore,” he said.

Data from a Medtronic-sponsored registry of heart-failure patients shows they are getting inconsistent, unstandardized care, according to a release published on devicelink.com. First, the data showed that patients without implantable cardioverter-defibrillators or cardiac resynchronization therapy-defibrillators were less likely to get appropriate drug therapies than patients with them. Second, patients in clinics with at least two nurses or physician assistants devoted to heart-failure patients received better care than patients in clinics with one or none. Third, some practices were much better than others at making sure heart-failure patients received drugs that lower blood pressure and relax veins and arteries. Previously, data from the registry showed that only 39% of eligible patients were receiving CRT, and only 51% of eligible patients were receiving ICDs.

Angiotech Pharmaceuticals Inc. (which despite its name is mostly a device company) announced a massive restructuring plan as a result of declining revenues. Its primary revenue source is royalties from the Taxus drug-eluting stent, marketed by Boston Scientific, which has been losing market share to new competitors from Abbott and Medtronic.

The firm said that, among other things, it will close a manufacturing and research plant in Rochester, NY by the end of 2009, eliminate an unspecified number of jobs, cut back on its obligations to a joint venture with Genzyme Corp., and delay the launch of a drug-coated catheter. It will also cut back on office and laboratory space in Vancouver, BC, Herndon, VA, and North Bend, WA. And it canceled a deal announced in July, in which the firm planned to sell $200-300 million in convertible notes to two investment firms in order to form a new operating unit and reduce debt. It was not going to meet the level of cash and cash equivalents required in the terms of the deal.

The firm said it will focus remaining investment and resources on its most promising near-term projects, mainly in the interventional radiology field. It will reduce spending on other R&D efforts.

Balloon Sinuplasty, pioneered by Acclarent Inc., is a technology that has come with a lot of hype and a lot of controversy. But now, two studies published in Otolaryngology - Head and Neck Surgery indicate that the technique is safe and effective, according to a company news release. The technology widens constricted sinus passages with specially designed balloons and catheters, and is an alternative to sinus surgery. But there has been much debate in the ENT sector over just how well it works.

The studies, which followed 109 patients starting in 2005, reported a 92% rate of functional patency after one year, an 85% rate of improvement in sinus symptoms after two years, and no serious adverse events or worsening sinus conditions. The technique has been used on about 40,000 patients since receiving FDA clearance in 2005.

Acclarent was named one of MD&DI’s 50 Companies to Watch in 2006.