In an agreement reached in mid-September, Medtronic (Minneapolis, Minnesota) decided to cut further legal expenses in its battle with Boston Scientific (BSX; Natick, Massachusetts) over rapid-exchange stent delivery systems and related products, with Medtronic saying it will pay BSX $175 million.
Together, the companies also called a halt to a range of other patent infringement hostilities, reporting that they struck a variety of agreements for cross-licensing of various patents covering abdominal aortic aneurysm (AAA) repair, embolic protection, nitinol technology and catheter manufacturing. "All lawsuits covered by the settlement will be promptly dismissed," the companies said in a joint statement. No other terms of the agreement were disclosed.
The $175 million settlement payment, they said, arises out of a German court case and a previous U.S. arbitration proceeding between the two companies involving Medtronic rapid-exchange stent delivery systems and angioplasty dilatation balloon catheters. Last year, Medtronic was forced to withdraw its rapid-exchange stent delivery system from the market as a result of the dispute, with a court decision requiring Medtronic to make a $169 million payment to BSX. Medtronic launched an appeal of that decision, but the new settlement agreements and payment appear to end that dispute.
Ceremony marks one year of life on AbioCor
Friday the 13th of last month meant very good luck for Tom Christerson, a recipient of the AbioCor artificial heart made by Abiomed (Danvers, Massachusetts). A ceremony marking the one-year anniversary of the implant was held that day at Jewish Hospital (Louisville, Kentucky), where surgeons Laman Gray and Rob Dowling performed the implant late in 2001. Besides being the only one of five implantees still alive in the trial – with two others not surviving the implant process – Christerson has become the poster patient for the device, since he has been able to return to his home in Central City, Kentucky, and carry on various activities. He offers the most positive case study of what the artificial heart can provide – a positive quality of life, not just additional survival time. Christerson has reportedly been able to go out to eat, go shopping and carry out various other activities of normal life. Before the implant, he could barely walk because of breathing difficulties, according to his clinical team.
Abiomed has continued to maintain its general policy of limited information concerning the clinical details of the trial – a stance taken to preserve patient privacy. But in announcing last month's celebration at Jewish Hospital, company spokesperson Sara Goldstein told Cardiovascular Device Update that the one year of life for Christerson was an important milestone for the company. Overall, Abiomed has accumulated more than 2.7 years of patient data from the trial.
Shortly before the one-year anniversary for Christerson, Abiomed held a news conference to update trial progress, saying that the lack of new patients in the trial over the summer months was largely the result of narrower criteria for patient inclusion in the trial. Among the standards for inclusion in the trail which have "raised the bar," according to David Lederman, president and CEO of the company, are a patient's fairly close proximity to the implanting hospital and the potential for the patient to leave the hospital and go home following implantation. Lederman said that the company was "disappointed but not discouraged" by the deaths of trial patients and that all the additional implants in the trial could come before year's end.
Positive data pushes partnership
Positive results from a Phase II study of RSD1235 in atrial fibrillation patients has prompted Cardiome Pharma (Vancouver, British Columbia) to go public with its search for developmental and marketing partners. The company said data from its 56-patient study demonstrated that RSD1235 appeared to be effective in terminating atrial fibrillation and in converting atrial fibrillation to normal heart rhythm. "We look at this as a major landmark for patients with atrial fibrillation and a major landmark for our company," said Alan Ezrin, Cardiome's chief scientific officer. "We're a small company working in a big space and very rarely do you get it right, and this one we got right." News of the research results, he said, "supports the fact that we have developed a team in cardiovascular medicine that we think is unparalleled."
Cardiome, which has been in business for about eight years and employs 33, developed RSD1235 in-house. "The uniqueness of this molecule is that it influences the function only of the atrial – or upper chambers of the heart – and as such, it will have a wider safety range than the other drugs that lack selectivity," Ezrin said. "These other drugs have some very serious cardiac side effects." There were no significant drug-related adverse events in the data released on RSD1235, the company said.
The next step for the company is to prepare for three Phase III studies, each one including 300 patients. Ezrin expects to enter Phase III sometime next year, and if all goes well, he said Cardiome should file its first application for regulatory approval (possibly the U.S.) in 2006.
In the meantime, the company will continue seeking a partner for RSD1235. "We've had a number of discussions around regional partnerships, that is, U.S. only or Europe only," said Bob Rieder, Cardiome president and CEO. "We expect that this data will now transform those discussions into negotiations." Also, he hopes the data will attract sophisticated investors who will see the value of the company.
Acist uses Sopheon's 4.0 Accolade
The whole process of remembering and envisioning, amending and editing, adding and subtracting, not to mention imagining and assessing – in short, the entire range of smart thinking – is difficult enough for one person or a small group of people in the product development business. So the thought of an entire company doing this, in an industry that thinks in terms of product development cycles of two years or less, is even more mind-boggling. One industry on such a timeline, of course, is medical technology.
Above all, that process is time-consuming, says Peter DeLange, director of product development for Acist Medical Systems (Minneapolis, Minnesota), a maker of contrast media injection systems used in cardiology, radiology and vascular surgery. "We spend an incredible amount of time communicating project status over and over and over," DeLange said. Thus Acist recently began searching for a formalized system that would provide immediate and continuing project updates "in a central location and letting us see all the information in terms of the current timing," plus all of the other aspects of product development.
The product it chose for this is the newest version of Accolade, the flagship product of Sopheon (Minneapolis, Minnesota/Guildford, UK). Accolade is a primarily online system that automates the various processes involved in product development in order to speed the cycle from first contemplation of a new product to commercialization – or, alternatively, saving time and money by scrapping a bad idea.
DeLange reports Accolade currently installed on Acist's Intranet, ready to be moved out to full access within the company, and to be used for gathering input on a project, for continually updating its progress and then offering access to that information to those who need it. "One of the product's key benefits is broad but targeted information accessibility," he says – not every fact of product development available to anyone in the company, he says, but "people that look at it only getting the information they need to do their job." This access provides top executives an overview of project progress while at the same time encouraging general participation with and general buy-in to the developmental effort.