Boston Scientific’s Forward Thinker
Using a drug was a novel approach to the problem of restenosis. Stents work on a simple principle: a balloon expands the stent to support the arterial wall and is then deflated and removed. Companies had tinkered with stent designs, trying to prevent restenosis, but with little success. “It was surprising that [only] a few companies were forward-thinking enough to look at biological approaches,” Hunter says.
Most of Boston Scientific’s products were typical low-risk medical devices, but it was open to unusual approaches. After a stint in Pfizer’s orthopedics division, Jim Barry joined Boston Scientific in 1992 to work on using angioplasty balloons to deliver drugs or even to assist in gene therapy. But progress was slow.
Barry found out about paclitaxel when he met Angiotech cofounder and consultant Lindsay Machan at a 1996 radiology meeting in Vancouver. Because restenosis is a problem with a number of implanted medical devices, and Boston Scientific manufactures devices for gastrointestinal, urological, and other uses, Barry realized that paclitaxel was “something we could leverage across all our divisions,” he says. He also liked that the drug was well known and had an extensive clinical history as a cancer treatment. “I thought it might reduce the regulatory burden,” says Barry, who is now Boston Scientific’s vice president of corporate research and advanced technology development.
Soon after he returned from Vancouver, Barry began to campaign for an agreement with Angiotech. Company managers were receptive, he recalls, but leery of the drug-eluting stent’s potentially long development time: they knew they were looking at much more than the 12 to 18 months it usually takes to bring a new medical device to market. Boston Scientific also had little in-house expertise in the clinical-trial and regulatory-approval process for drugs, which is different fromand often more stringent than – that for medical devices. At the same time, it knew it might have a blockbuster on its hands.
And Angiotech was an attractive partner. Earlier in 1996, its paclitaxel-coated stents had been tested for the treatment of patients with cancer of the esophagus. As Angiotech had hoped, the drug prevented new tissue from growing over the top of the stents. Subsequent studies have since shown that paclitaxel works by inhibiting cell migration, markedly slowing the accumulation of scar tissue.