St. Jude Wins European Approval for Blood Pressure Device

St. Jude Medical Inc., the second-biggest maker of heart-rhythm devices, won European approval of its product to treat hypertension by searing the nerves that contribute to high blood pressure.

St. Jude received CE Mark approval for the device known as the EnligHTN renal denervation system, the St. Paul, Minnesota-based company said today in a statement. The product uses multiple electrodes to sear the nerves in the arteries that lead to the kidneys and boost blood pressure. It is used for patients who don’t respond to conventional medical therapy.

The system will compete against similar products from Minneapolis-based Medtronic Inc., the leader in a market analysts estimate may generate $3 billion in annual sales, Dublin-based Covidien Plc and closely held Vessix Vascular Inc., based in Laguna Hills, California. All four devices use radiofrequency energy to destroy a tiny portion of the sympathetic nerves and quell their overactivity.

“The EnligHTN renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension,” said Stephen Worthley, a researcher from the Royal Adelaide Hospital in Australia who is helping develop the product. The multielectrode device “provides an efficient and effective alternative treatment for patients with resistant hypertension and has the possibility to change the way that hypertension is treated.”

Patient Population

More than 1 billion people worldwide have hypertension, which increases the risk of having a stroke, heart disease or kidney failure. About 25 percent of patients aren’t able to get their blood pressure to recommended levels using currently approved medications, St. Jude said.

The EnligHTN system has multiple electrodes on a catheter that is threaded into the kidney artery, allowing doctors to ablate the nerves in an efficient and reliable manner, the company said. The device can produce four ablations in 90 seconds, potentially saving time, cutting costs and reducing the exposure to radiation.

St. Jude plans to introduce the device this week at the EuroPCR meeting on interventional technologies in Paris. The company will present data tomorrow on the safety and effectiveness of the system.

St. Jude fell 2 percent to $38.89 at the close in New York. The shares have fallen 25 percent in the past 12 months.

Before it's here, it's on the Bloomberg Terminal. LEARN MORE