Linked to the future

  • Article by: JANET MOORE , Star Tribune
  • Updated: September 18, 2009 - 9:47 PM

Retiree Rollie Crawford thought he was returning to Minnesota for some family time and wound up helping Boston Scientific test a new heart stent.

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Rollie Crawford thought his recent visit to Minnesota would involve some time with his family, especially his grandchildren.

But as it turned out, the 69-year-old Minnesota native found himself at Abbott Northwestern Hospital, suddenly enrolled in a clinical trial evaluating a new heart stent made by Boston Scientific Corp.

Crawford, now retired in Bonita Springs, Fla., was a lawyer with the prominent South St. Paul law firm LeVander, Gillen & Miller, and a member of the Allina Hospitals & Clinics board for seven years, serving as chairman for two years.

Now he's playing a role in Minnesota's civic and medical community again.

On Friday, Boston Scientific said it has completed enrollment in a study of 1,532 patients at 140 hospitals worldwide, including Mayo Clinic, Abbott Northwestern Hospital and St. Mary's health system in Duluth.

Crawford was among those participating.

The pivotal five-year study, called Platinum, was designed to support Boston Scientific's application for Food and Drug Administration (FDA) approval of its next-generation drug-coated stent, called Promus Element. FDA approval is predicted for mid-2012, while European regulatory approval is expected this year.

Part of a $4 billion global market, stents are tiny mesh struts that are used to unclog heart arteries. When coated with drugs, the arteries are less likely to reclog.

A new stent for Boston Scientific's portfolio means the Natick, Mass.-based company won't have to pay 40 percent royalty fees on sales of the original Promus stent to Abbott Laboratories. "That's a meaningful bit of profitability that they're leaving on the table,'' said Brooks West, an analyst at Craig-Hallum Capital Group in Minneapolis.

The unusual arrangement -- the first of its kind in medical technology -- stems from Boston Scientific's $27 billion purchase of Guidant Corp. in 2006. Guidant's stent business was spun off for $4.1 billion to Abbott, which launched its Xience drug-coated stent last year.

Xience and Promus are the exact same stents, only Boston Scientific pays royalties every time it sells a Promus stent. (The company does not break out sales of individual products.) The agreement expires in June 2012, prompting analyst Tim Nelson at FAF Advisors in Minneapolis to wonder whether the company's timeline for FDA approval is too optimistic.

A key step for Boston Scientific to remove the financial yoke involves a clinical trial assessing the safety and effectiveness of the new Promus Element stent. The study pits the new stent -- which is made out of a platinum chromium alloy, and has thinner struts -- against the original version.

That's where Crawford comes in. After doctors in Florida performed a series of tests, Crawford brought the results to the Minneapolis Heart Institute in July. Doctors discovered Crawford's left anterior descending artery was blocked -- a big artery referred to as the "widowmaker" because a blockage there is often deadly.

No one was more surprised than Crawford. An active tennis player and golfer -- he even bikes to his thrice-weekly golf game -- he says he didn't experience any classic heart attack symptoms.

When asked to enroll in the Boston Scientific clinical trial, Crawford immediately agreed, saying he's "interested in helping people figure out what's better for patients."

But because the study is blinded, Crawford doesn't know which stent he was treated with.

Either way, he said, he's glad it's a stent made by Boston Scientific, which employs 5,000 people in the Twin Cities. That's because his son, Jeremy, works for the company as a product manager.

Janet Moore • 612-673-7752

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