An Illinois district court last month denied a motion by Cook (Bloomington, Indiana) related to an injunction concerning that company's agreement with Guidant (Indianapolis, Indiana) in their continuing battle with Boston Scientific (Natick, Massachusetts) over the development and marketing of drug-coated stents. In the motion ruled on, Cook had asked the court to determine that a previous injunction does not prohibit it from purchasing stents and balloon catheters from Guidant on an original equipment manufacturer (OEM) basis. Instead, the judge in the case declined to rule on that issue, recommending that a declaratory judgment might be more appropriate.

Cook and Guidant have been in conflict with Boston Scientific over paclitaxel-coated stents designed to treat coronary arteries and retard restenosis. In November, an appeals court denied requests by the two companies to stay a permanent injunction prohibiting them from using data from a clinical trial to prove the effectiveness of their drug-coated coronary stent. Boston Scientific won the injunction last Oct. 1, asserting the two companies' sales agreement was illegal under terms of the co-exclusive licensing agreement Cook and Boston Scientific have with Angiotech Pharmaceuticals (Vancouver, British Columbia), the company that is providing the paclitaxel formulation.

Cook issued a statement on the latest decision, adding a positive spin. Kim Hawkins, company president, said, "We were pleased that the court did not object at this time to our proposed OEM relationship with Guidant." He added, "We are carefully considering the court's ruling and will proceed at the appropriate time."

Industry watchers saw the development as a negative for Cook and Guidant, saying that it delays their ability to bring such a device to market. Kurt Kruger, an analyst with Banc of America Securities (San Francisco, California), said the ruling means the companies will have to either seek a declaratory judgment or proceed with their plan and risk violating the injunction. He said that the injunction had offered the two firms "a wild-card hope" which they can can no longer bank on.

Boston Scientific issued a statement saying that the injunction prevents Cook from distributing paclitaxel-coated stents through another party in a manner inconsistent with the companies' license agreement with Angiotech. Boston Scientific also said the injunction prohibits the use of clinical and other data generated in connection with the Cook/Guidant agreements for any commercial purpose, including obtaining regulatory approval to sell paclitaxel-eluting stents in the U.S. or elsewhere.

Heart monitoring device calls for help

A miniature device that reads a heart rate monitor and automatically forwards a warning call to a predetermined cell phone number such as that of a physician, caregiver or emergency services if the user is in distress, could soon aid people at high risk of cardiac problems. A team from IBM Engineering and Technology Services, a division of IBM (Armonk, New York), said it has successfully tested the relay device and is actively seeking a customer to turn it into a consumer product.

When a person wearing the device reaches a predetermined heart rate, which might indicate a cardiac distress level, a signal is sent wirelessly via Bluetooth, a short-range, low-power radio frequency technology that makes communication possible between personal digital assistants, laptop computers, printers and mobile phones. It remains to be seen whether the instrument will be produced and marketed by a medical device company, a cell phone network provider or an athletic equipment manufacturer. But the designers said they envision a variety of uses for it and are busy working on variations on the original theme.

According to company spokesperson Carl Ziter, IBM wouldn't actually turn this device into a product. "We wouldn't create the product; we'd be the service organization that helped build it for someone else," he told Cardiovascular Device Update. Anticipating the obvious pricing question for such systems, he said it "depends on the company who signs with us and what they want us to put into it." However, he noted that the core technology itself is inexpensive to produce and that most customers for the technology will use it in relatively simple applications. "I think it's safe to say that people we work with will be looking for it as a mass implementation. They're not going to be looking for it as a complex specialized chip."

Heart rate measurement devices have been on the market for some time, and they are especially popular with joggers and bikers and generally are worn strapped to the chest. These devices measure how many times an athlete's heartbeats per minute. However, this new device takes that technology a step further. "Suddenly we were able to send heart rate information over cell phone networks," said Bryan Striemer, a development engineer for IBM and one of the inventors of the device, in a Reuters interview.

"We've not only built a new concept model but have actually demonstrated this first-of-a-kind device, proving it works," Pat Toole, general manager of IBM Engineering & Technology Services, said in a company statement.

During that demonstration, someone wearing a standard heart rate monitor chest strap was given a radio frequency relay device (about the size of a pack of chewing gum) and a personal digital assistant with special IBM software. A volunteer from the audience, posing as a concerned relative or fitness coach, was given a standard cell phone with what is known as short message service capability. When the person performing the demonstration reached the "at risk" level, the device instantly sent a message and the audience volunteer read the actual heart rate to the crowd.

"A device such as this that sends out an alarm also could be worn by an elderly person who might find additional comfort in knowing any significant heart-related episode would be reported," Toole said. "This could offer great peace of mind for those in need of assisted living." The company said the relay device also is perfect for runners or bikers who want to continue with vigorous exercise but have had certain heart problems in the past, creating a need to "watch and listen."

One issue that still needs to be addressed is how to incorporate technology into these devices so that they will be able to effectively track an individual with such a system. "The tracking part of it is perhaps the most important function," Ziter noted. He said IBM is working on incorporating global positioning technology into a version of the device that would enable an elderly person or someone suffering from Alzheimer's disease who became lost or confused to send their whereabouts to their children or a designated caregiver's cell phone.

The company also must find a way to enable this technology to track patients over greater distances. "Admittedly, Bluetooth is a short range," Ziter said. He believes future experiments should help answer such questions as whether or not the technology can be relayed, and whether it can send messages to servers and be routed on the Internet. However, he noted that the initial demonstration is noteworthy, especially due to its novelty. "As best we can tell," he said, "we're the first [company] to actually make this work in this fashion. That in itself makes this an important first step."

Alliance spinning Imagent to Photogen

In a spin-off move that, as the sportswriters might say, could benefit both teams, Alliance Pharmaceutical (San Diego, California) agreed to sell off its medical imaging assets primarily related to its Imagent product to Photogen (New Hope, Pennsylvania). The deal offers a large upside for Photogen, and is being bannered enthusiastically by Taffy Williams, company president, saying that Imagent will add greatly to its new emphasis on medical imaging, especially for opportunities in the cardiovascular sector. It also could help Alliance by allowing that company to focus on development of its oxygen therapeutic product Oxygent, which has hit regulatory rough waters via clinical and financing setbacks.

Williams said "significant financing-related issues" are yet to be worked out, but he expressed strong optimism about the deal and its ability to push Photogen's new focus on the imaging space, and he listed a variety of strong match-ups between the company's altered mission and the assets acquired. Alliance, he said, "has an FDA-approved product [Imagent] ... has a product available for launch, already has a number of sales reps trained, has manufacturing capability that could be used to make the product, and the people and ability to launch it in the first half of next year."

Photogen has turned its attention to the imaging arena after splitting off its photodynamic therapeutic and laser device assets to five founding shareholders in August and reorganizing the remaining portion of the firm keyed to diagnostic imaging. In late October, it restructured financing and raised $89 million through the sale of common stock.

Alliance received FDA clearance for Imagent, an ultrasound imaging material for imaging of the left ventricle of the heart, last June. Formerly known as Imavist, Imagent was cleared for patients with suboptimal echocardiograms to opacify the ventricle, thus improving visualization of its pumping activity and helping to delineate diagnosis and possible therapies. Other benefits of the acquisition would be Alliance's marketing agreement with Cardinal Health (Dublin, Ohio) and recently approved reimbursement codes covering the imaging procedure.

Tissue engineering alliance

The increasingly tenuous boundaries between biotechnology and conventional medical devices may have become even less defined with a new agreement that may produce the world's first tissue-engineered heart valves. Edwards Lifesciences (Irvine, California), a developer of products and technologies to treat advanced cardiovascular disease, and Cook Biotech (West Lafayette, Indiana), a developer of tissue-engineered biomaterials, have entered into an exclusive technology licensing and supply agreements to pursue the development of what they termed "living" heart valves and related cardiovascular implants using porcine-based biomaterials developed by Cook Biotech.

Cook Biotech, part of the Cook Group (Bloomington, Indiana) manufactures tissue-engineered medical products from the submucosal layer of porcine tissues. This tissue is harvested and developed into a strong, pliable biomaterial that provides a rich environment for cell attachment and growth. This technology has already been road tested for several applications, and is currently incorporated into biocompatible scaffolds to make medical products for surgical repair of hernias, wounds, burns and other soft-tissue injuries including the lungs. Edwards obtains an exclusive worldwide license to submucosa tissue technology developed by Cook Biotech, as well as access to all related intellectual property rights for development of specific cardiovascular implants. Financial details of the agreements were not disclosed.

Michael Mussallem, president and CEO of Edwards, told CDU that he believes that in the future, there will probably be even more such biotech/ medical device combinations on the market. "I wouldn't be surprised to see more and more interaction of biotechnology with medical devices as we try to address unmet clinical needs." Like many other such endeavors with hybrid products, however, he cautioned there might be a lengthy engagement process before the technologies are successfully wed to form a functional product, perhaps taking as long as five to 10 years, and there is always the chance that the process will not work at all. But while he characterized the agreement with Cook Biotech as an "early development," he also said that it holds "a lot of promise."

According to the company, each year more than 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves. Mussallem said that a successfully developed artificial heart valve could have an immediate impact on the current need for donor valves, and younger patients would stand to benefit the most from a bioengineered device, with the heart valve able to grow with the child vs. the current need for continual replacement of the valves as a child ages.

Companies ... in brief

Cardiac Science (Irvine, California) said the Wyoming Department of Health has purchased 122 Powerheart automated external defibrillators (AEDs) for deployment in rural areas throughout the state. The AEDs will be placed in public facilities, fire and emergency services vehicles and regional healthcare centers. The AED purchases were made through a $250,000 federal grant to the Department of Health's Office of Emergency Medical Services under the Rural Access to Emergency Devices Act ... Myogen (Denver, Colorado) received a $750,000 Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health (Bethesda, Maryland). The two-year grant will be used for Myogen's drug discovery program aimed at the identification of lead compounds that inhibit MEF2 dependent signaling as a treatment of chronic heart failure.