St. Jude gains CE mark for quadripolar CRT pacer

St. Jude Medical ($STJ) scored European regulatory approval for a new quadripolar cardiac resynchronization therapy pacemaker. And with an immediate commercial rollout, the company gains another product that could help reverse sluggish revenue in the sector.

The CE mark status covers the Allure Quadra CRT pacemaker, a product designed to help manage heart failure. It is something that Minnesota-based St. Jude bills as the first of its kind with quadripolar leads. Such an advance allows for more efficient pacemaker implants (better options for lead placement) and a smaller amount of follow-up surgeries to reposition leads, the company said.

St. Jude doesn't have approval in the U.S. yet but it is already eyeing a sizeable market in Europe. The company estimates more than 3.6 million hospitalizations related to heart failure take place in Europe each year and is billing its latest pacer as something that could help manage those conditions and reduce hospitalizations. In other words, products that boost care and save the healthcare system money at the same time are a good thing these days.

New products in the cardiac rhythm management space couldn't hurt, considering St. Jude and its rivals around the world continue to face sluggish sales in the segment because of everything from stagnant demand to pricing pressures and reimbursement cuts. St. Jude's 2013 first quarter experienced sluggish revenue once again, largely because of declining CRM sales, and the company expects the segment will face a 4% revenue drop for the year. But St. Jude said a launch of a number of new products in a number of areas should counter this, and a new, technology-forward CRT pacemaker is likely part of that strategy.

Meanwhile, a product St. Jude Medical sold to Vascular Solutions is hitting the market again. The Minneapolis company announced it was re-launching the Venture deflectable-tip catheter after buying it up from St. Jude Medical in August 2012. At its peak, the catheter generated $3 million in annual sales, $2 million of which came from the U.S.

- read the St. Jude CE mark release
- here's the Vascular Solutions announcement

Suggested Articles

J&J launched a virtual clinical study to gauge whether Apple’s iPhone and ECG-enabled smartwatch can help reduce the risk of stroke and catch AFib.

The Salt Lake City-based developer said its Logix Smart test is now available to be exported from Utah to countries requiring the CE Mark.

Dexcom received a new European approval for its wearable continuous glucose monitor in pregnant women across Type 1, Type 2 and gestational diabetes.