EVOLVE II Trial Represents the First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Stent

In the first successful U.S. pivotal trial of a bioabsorbable polymer stent, the Boston Scientific (NYSE: BSX) SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium Coronary Stent System met its primary endpoint in this non-inferiority study, which evaluated the one-year rate of target lesion failure (TLF).

Additionally, favorable rates for key secondary endpoints were observed with the SYNERGY Stent. Dean Kereiakes, M.D., F.A.C.C., F.S.C.A.I., the principal investigator for the EVOLVE II Trial, presented the study results today in a Late Breaking Clinical Trial session at the American Heart Association Scientific Session 2014 in Chicago.

Key findings for the SYNERGY Stent from the EVOLVE II Trial include the following:

• At 12 months, the TLF rate was 6.4 percent per protocol (p=0.0003 for non-inferiority) and 6.7 percent for intent-to-treat (p=0.0005 for non-inferiority).
• Stent Thrombosis (ST) was rare, with Definite or Probable ST occurring in only 0.4 percent of patients through one year. No Definite ST occurred after 24 hours.

“The one-year data from the EVOLVE II Trial, particularly the exceptionally low stent thrombosis rate, are encouraging because this is a complex patient population,” said Kereiakes, who is medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati.“Having a bioabsorbable polymer stent with this type of performance is important to physicians and health care systems. In addition, there is great enthusiasm for a product that is very deliverable and user-friendly. From an operator perspective, the SYNERGY Stent makes cases easier.”

The EVOLVE II Trial is a global, multi-center, randomized, single-blind, non-inferiority pivotal trial designed to evaluate the performance of the SYNERGY Stent System compared to the durable polymer PROMUS Element™ Plus Drug-Eluting Stent (DES) System. The trial enrolled 1,684 patients in 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. Patients demonstrated both clinical and angiographic complexity to a degree not observed in prior U.S. pivotal trials for DES. More than 25 percent of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75 percent of patients had AHA/ACC class B2 or C coronary lesions.

The EVOLVE II Trial is part of a rigorous clinical program designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the SYNERGY Stent.

“The EVOLVE II Trial adds to our growing body of knowledge about the promising SYNERGY Bioabsorbable Polymer Stent, which is designed to provide early healing and freedom from long-term polymer exposure,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “It also supports key findings from the EVOLVE FHU study, where data through three-years demonstrate excellent long-term outcomes.”

Significant Relief Achieved Using Advanced Illumina™ 3D Programming Software

New retrospective data evaluating the Boston Scientific Corporation (NYSE: BSX) Precision Spectra^™ Spinal Cord Stimulator (SCS) System demonstrate that the device provided sustained, highly significant relief of low back pain 12 months after implantation. Results from the PRO Study are being presented this weekend at the 18th North American Neuromodulation Society (NANS) meeting in Las Vegas.

The outcomes review of 213 patients at 13 centers focuses on patients with chronic pain and chronic low back pain who are receiving treatment with the Precision Spectra SCS System. The system’s Illumina™ 3D Software, an anatomy-driven computer model designed for simple point-and-click pain targeting, helps to address a key challenge in long term back pain relief: stimulating the neural target without stimulating undesired areas.

At 12 months post-implantation, results include:

• Sustained and significant reduction in overall pain measured on the 0-10 numeric rating scale (NRS) was reported, from an average baseline score of 7.17, to an average score of 2.96 at 12 months post-implantation (N= 178).
• In patients with only low back pain (N= 73), a sustained and significant reduction of low back pain (measured on the 0-10 NRS scale) was reported, from an average baseline score of7.21 to an average of 3.17 at 12 months post-implantation.
• In patients with severe low back pain (N= 41, baseline score of 8 or greater measured on the 0-10 NRS scale), sustained and significant reduction in pain was reported, from an average score of 8.60 at baseline to 2.87 at 12 months post-implantation.

This cohort will be followed through the 24-month interval.

“Treating low back pain has been challenging because so many therapies have had mixed results,” said Salim Hayek, M.D., Ph.D., chief, Division of Pain Medicine at University Hospitals of Cleveland and lead study investigator. “These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from this difficult to treat condition.”

“When designing the next-generation Precision Spectra SCS System, we included new, innovative technologies with the goal of treating low back pain more effectively,” said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. “This long-term, ‘real-world’ study reflects our continuing commitment to advancing the science of pain relief to help achieve better outcomes for patients with chronic pain.”

Together with the clinical data presented at NANS, additional presentations will describe an advanced research program of investigational studies of Boston Scientific SCS systems. These studies include ACCELERATE, a prospective multicenter trial evaluating conventional high-rate (10 kHz) spinal cord stimulation in the management of chronic, intractable pain, and WHISPER, a prospective multicenter trial evaluating the use of sub-perception multiple independent current control (MICC) SCS at up to 1.2 kHz.

About Chronic Pain

Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients; without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally. In particular, conventional spinal cord stimulator therapy can be effective in treating low back pain but not all patients get optimal relief. As a result, there is a continuing need for new therapies and technologies to meet this very specific pain area.

About the Precision Spectra SCS System

Recently, Popular Mechanics magazine awarded the Precision Spectra System the 2014 “Breakthrough Award” in the field of medical devices for its innovation in meeting the needs of patients with chronic pain. The Precision Spectra SCS System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, which is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.

Prior to the release of the Precision Spectra SCS System, SCS systems offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of a single lead. Additional lead ports give physicians more flexibility to cover their patients’ pain at the time of implant and more flexibility to adapt to changing pain patterns in the future. With more contacts, the Precision Spectra SCS System also offers more coverage of the spinal cord for the management of chronic pain.

The upgradeable Precision Spectra SCS System is designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. A key challenge in SCS therapy is stimulating the neural target without stimulating undesired areas. By taking into account the conductivity of 3D anatomical structures and physician placement of the SCS leads, the Illumina 3D Software is designed for simple point-and-click pain targeting.