Boston Scientific ($BSX) is facing a stinging setback in the highly competitive neuromodulation field as the company's vagus nerve stimulation (VNS) device failed to improve cardiac function in a recent mid-stage clinical trial.
As Reuters reports, the med tech giant's NECTAR-HF trial enrolled 95 heart failure patients in Europe and implanted Boston Scientific's VNS device near the vagus nerve. Some patients received regular stimulation, while others had the devices switched off. At the end of six months, the study showed no difference between the two groups, according to results unveiled on Saturday at the annual meeting of the European Society of Cardiology (ESC).
The device's failure came as a surprise to researchers, as pre-clinical findings yielded more promising data, study leader Faiez Zannad told Reuters. But the product's poor performance could be attributed to multiple factors, including the short, 6-month evaluation time and the strength of the electrical pulse used to stimulate the vagus nerve, Zannad said.
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| Boston Scientific's Vercise DBS system--Courtesy of Boston Scientific |
The results do not bode well for Boston Scientific, as the company attempts to ramp up its neuromodulation efforts and stay abreast of competitors. In April, the company launched a new clinical trial of its implantable deep brain stimulation (DBS) device in Parkison's patients at international hospitals. The study builds on previous data from a 6-month study which showed that Boston Scientific's Vercise DBS delivered a 60% average improvement in motor function in 40 patients with 100% implant success.
Meanwhile, archrivals St. Jude Medical ($STJ) and Medtronic ($MDT) are hard at work on their own neuromodulation products, inking deals and expanding their offerings for chronic pain and neurodegenerative diseases. Last month, St. Jude finalized its acquisition of interventional pain management therapy manufacturer NeuroTherm and Medtronic snatched up Netherlands' neuromodulation outfit Sapiens Steering Brain Stimulation for $200 million, strengthening its hold on the market.
Boston Scientific also faces competition from up-and-coming neuromodulation outfits developing innovative devices for chronic pain and depression. Houston, TX-based Cyberonics touts its FDA-approved, VNS device for refractory epilepsy and treatment-resistant depression, and is rolling out a new VNS system to monitor and reduce seizures. ElectroCore, a startup with a noninvasive vagus nerve (nVNS) stimulation therapy for migraines, is pushing for FDA approval for its device and hopes to bring its product to the U.S. market within the next 12 to 15 months.
- read the Reuters story
Special Report: So far, just 4 companies have a shot at winning the neuromodulation race - Boston Scientific - Working hard to reach Medtronic