Device received CE mark in 2012
By Omar Ford
Boston Scientific Corp. is entering into the deep brain stimulation (DBS) market in the U.S. with its latest FDA-approved technology. The Marlborough, Mass.-based company revealed on Monday that it has received approval for the Vercise deep brain stimulation system. News of the FDA-nod caused Boston Scientific (NYSE:BSX) shares to increase by 2 percent in after-hours trading Monday. The slight increase comes on the heels of a 7.5 percent drop in shares the company experienced in late November, when it said it would delay commercialization efforts of its Lotus Edge aortic valve system. (See BioWorld MedTech, Nov. 30, 2017.)
Vercise is used to treat the symptoms of Parkinson's disease (PD) and works by stimulating a targeted region of the brain through implanted leads.
The DBS system's FDA approval was based on the INTREPID study, a multicenter, prospective, double-blind, randomized sham-controlled study of DBS for Parkinson's disease in the U.S.
The INTREPID study evaluated the safety of the system in 292 patients at 23 sites and also evaluated its effectiveness. It successfully met its primary endpoint of mean change in waking hours with good symptom control (n=160). Data from the INTREPID study is expected to be released in 2018.
"The U.S. study is one of the only double-blind, randomized and sham-controlled study that's ever been done in the DBS space," Maulik Nanavaty, senior vice president and president, neuromodulation at Boston Scientific, told BioWorld MedTech. "[INTREPID] wasn't an easy undertaking, but I feel it significantly adds a very robust set of data and clarity on how the therapy benefits the patient."
The FDA filing was also supported by safety data from the European multicenter, prospective, single-arm VANTAGE study. In the VANTAGE study, 40 patients treated with the Vercise DBS system demonstrated a 63 percent improvement in motor function at 52 weeks from baseline.
"That's a pretty significant improvement for the patient," Nanavaty said. "We continue to see consistent benefits to patients and the patients we have treated in the last five years."
Boston Scientific has had a CE mark for Vercise since 2012.
The technology has helped push growth for the firm's neuromodulation division, said Michael Mahoney, Boston Scientific's president and CEO, during a 3Q17 earnings call.
"In neuromodulation, revenue grew 11 percent in 3Q17 driven by strength in spinal cord stimulation market, sales of our Montage MRI platform, as well as continued strong uptake of the Vercise MRI DBS system in Europe," Mahoney said.
Competition in DBS market
With Vercise's FDA approval under its belt, Boston Scientific can compete against Medtronic plc's Activa PC DBS system and Abbott Laboratories Inc.'s Infinity device in the U.S.
Medtronic first gained FDA approval for Activa in 2009. Abbott received approval for Infinity in October 2016. (See BioWorld MedTech, Oct. 6, 2017.)
Abbott gained access to Infinity through the $25 billion acquisition of St. Jude Medical Inc. that closed earlier this year.
Joshua Jennings, an analyst with Cowen and Co., said there was still room for growth in the DBS market.
"Vercise is to enter the $600 million high growth and under-penetrated U.S. DBS market as a viable alternative to current market leader Medtronic's Activa PC system and St. Jude's Infinity device," Jennings said.
Boston Scientific has some advantages over previous DBS offerings. The device was developed from a foundation of cochlear implant technology, designed to specifically stimulate auditory nerves to produce a sense of hearing.
"Key differentiating features of Vercise include the smallest rechargeable implantable pulse generator on the U.S. market and proprietary technology that enables the device to independently control the level of current delivered by each electrode in the implanted leads," Jennings said. "Other features of the platform include a battery life of 15 plus years, leads with eight contacts combining for a total span of 15.5 mm, tight 0.5 mm spacing between each contact and multilumen construction."
Boston Sci's DBS future
Nanavaty said Boston Scientific has launched a website, dbsandme.com, to help patients with PD become familiar with the technology and garner information with DBS therapy.
The company also plans to garner approval in the U.S. for another iteration of its DBS technology, the Vercise Gevia rechargeable system. The technology received the CE mark in June. Nanavaty said the Vercise Gevia system allows patients to benefit from directional stimulation within a rechargeable system while maintaining the ability to have an MRI. U.S. commercialization of Vercise Gevia along with the Vercise PC is expected in the second half of 2018.
Boston Scientific's technology is also being used in a Cleveland Clinic study to assess DBS potential to improve movement in patients recovering from stroke. The clinical trial was reported in January.
"We're looking at patients who have completely lost functionality to provide stimulation and to provide physical rehabilitation to bring them back to bringing functionality," Nanavaty said. "We're very excited about the options and alternatives it may be able to provide to the physician communities and to the patients."
Published December 13, 2017