UPDATE: Vessix in hand, Boston Scientific targets Medtronic in high blood pressure market

Boston Scientific acquires Vessix

Boston Scientific (NYSE:BSX) is confident that it will be the 2nd player in the U.S. market for renal denervation, executives told MassDevice.com today, stressing their belief that the Vessix Vascular high blood pressure treatment acquired today is superior to competing offerings from arch-rivals Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ).

"We believe we’ll be 2nd to market with a highly differentiated technology, a true 2nd-generation device," Jeff Mirviss, president Boston’s peripheral interventions business," told MassDevice.com today.

Laguna Hills, Calif.-based Vessix makes the V2 renal denervation system. Boston Scientific agreed today to pay up to $425 million for Vessix, with a $125 million up-front payment and another $300 million in milestone payments out to 2017.

In renal denervation, the nerves lining the renal arteries, believed to play a role in high blood pressure (or hypertension), are ablated with radiofrequency energy. Dr. Keith Dawkins, global chief medical officer for Boston Scientific, told us that the procedure has proven safe and efficacious out to 3 years in clinical trials.

"The data from the interim analysis of the Vessix trial presented at TCT showed impressive reduction of both systolic pressure and diastolic pressure out to 6 months," Dawkins said.

Unlike Medtronic’s Symplicity device and its single electrode, the Vessix V2 system’s multiple electrodes fire simultaneously. St. Jude’s Enlightn device also features multiple electrodes, but they fire sequentially, not simultaneously. That means the Vessix device can accomplish the procedure in about 30 seconds, compared with up to 30 minutes for the other devices, Mirviss said.

The V2 device won CE Mark approval in the European Union in May and is also approved for the Australian market. That gives BSX a leg up in getting the device onto those markets, Mirviss said.

"That will give us an entree into literally dozens of companies around the world. We’ll be putting this into our vast distribution channel to maximize the impact of this therapy," he said. "In 2013 or early 2014, we expect to begin an [investigational device exemption] trial to work toward commercialization in the U.S. and other key geographies."

Dawkins said Boston Scientific’s internal renal denervation program will be subsumed into the Vessix operation, under the umbrella of Mirviss’ PI segment. The internal program gave BSX renal denervation knowledge that will stand it in good stead, Dawkins said.

"We’ve had an internal program for some time. We’ve learned a lot about renal denervation in general and done a lot of preclinical work. The opportunity for this, what we think is a truly differentiated product, was really too good to miss from the acquisition point of view," he said.

Several features add to that differentiation, Mirviss and Dawkins told us.

"It’s hypothesized that some of the non-responders with the Medtronic device was due to the fact that it’s uncertain that the ablation has actually occurred. This device provides direct, real-time feedback to the physician as to whether the electrodes are in contact with the vessel wall," Mirviss explained. "It also indicates whether the device is in a place it shouldn’t touch. For example in the osteum of the artery, the device will not turn on."

With reducing costs the new holy grail of healthcare, Mirviss and Dawkins said the V2 device could defray costs by reducing the incidence of the serious complications attendant to hypertension.

"Imagine a patient with very high blood pressure, uncontrolled with current medication. They are at a significantly higher risk of death, as well as a higher risk of adverse events like stroke, heart attack, heart failure and kidney failure," Mirviss said. "If we could delay or eliminate major events like strokes, heart failure or heart attacks, that will save the healthcare system a significant amount of dollars."

"You don’t have to reduce the stroke rate by very much to make a profound economic impact on healthcare costs," Dawkins added.

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