St. Jude’s Quadripolar Lead Sparks Debate Among Competitors

St. Jude Medical, Inc. has developed a quadripolar lead designed to better manage phrenic nerve stimulation (PNS) and other potential complications from defibrillator leads that cause diaphragm contractions through the nerve. The quadripolar lead has been dismissed by St. Jude’s competitors, though none have been as vocal or proactive as Boston Scientific Corp.

St. Jude expects the new leads to be on the market in mid-2011—at least 18 months before rival products—pending U.S. Food and Drug Administration approval.

Boston Scientific Chairman, President and CEO Raymond Elliot recently labeled the new lead “99 percent hype” and developed a way to counteract. The Natick, Mass.-based company announced last week that U.S. implant centers that replace one of their defibrillators with a competing device because of “unmanageable chronic phrenic nerve stimulation” may qualify for a refund.

“With this warranty program, we are firmly standing behind the performance [of Boston Scientific’s devices],” Hank Kucheman, group president of Boston Scientific’s Cardiology, Rhythm and Vascular business, said in a news release.

The warranty program covers hospitals for six months after a patient receives a defibrillator. A Boston Scientific spokesman clarified that the company won’t cover hospitalization costs, but would offer full reimbursement for the defibrillator and lead, while patients would receive up to $2,500 to cover unreimbursed medical costs.

Of course, it remains to be seen how the new lead will affect the cardiac resynchronization therapy defibrillator (CRT-D) market. It may come down to each purchaser’s degree of optimism—those who share Elliott’s view likely will find the warranty a practical solution, while others with faith in the technology behind the quadripolar lead will opt for it, in effort to reduce PNS and other complications for patients.

Leerink Swann recently held a conference call with an electrophysiologist from a high-volume east coast center to discuss the potential impact of St. Jude’s lead (Leerink Swann declined to disclose the name of the physician). The doctor, a frequent user of St. Jude products, had performed approximately a dozen implants with the lead.

The physician stated that the lead represents a “quantum leap” forward in current bipolar cardiac resynchronization therapy (CRT) lead technology, and substantially will reduce or eliminate common CRT complications including PNS.

The physician further stated that the quadripolar lead could make CRT implants more efficient, reduce therapy non-responder rates and potentially further improve CRT benefits to hemodynamic function. He also noted that he has not had a higher lead dislodgement rate with the quadripolar lead compared with other left ventricular lead systems. And while quadripolar leads can be programed to work as bipolar, these leads offer more choices to create bipolar stimulation, which could increase the chances of better outcomes.

Leerink Swann analysts said the call encouraged them regarding the value of St. Jude’s quadripolar lead. They anticipate that the CRT-D market is likely to largely convert to quadripolar leads, mimicking the past conversion from unipolar to bipolar lead technology.