相关临床试验
9
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中(未招募)
1
11.1%
已完成
4
44.4%
招募中
2
22.2%
终止
1
11.1%
撤回
1
11.1%
暂无批准数据
- Aetna has updated its medical policy to cover both SPR's SPRINT PNS System and Curonix's Freedom PNS System for intractable neuropathic pain, expanding access to 22.3 million covered lives. - The SPRINT PNS System offers a 60-day treatment without permanent implant, while the Freedom PNS System provides a permanent, MR-conditional solution powered by electromagnetic coupling. - Additional commercial coverage from Health Alliance Plan of Michigan, Select Health, Sentara Health Plan, and University of Utah Health Plans extends access to an additional 27 million covered lives nationwide. - These coverage decisions represent significant progress in providing non-opioid, minimally invasive treatment options for millions of Americans suffering from chronic pain.
- Curonix's Freedom Peripheral Nerve Stimulator System achieved a 69% response rate with ≥50% pain reduction at three months compared to only 11% in the control group (p<0.001). - The active stimulation group reported a 62% mean reduction in Visual Analog Scale pain scores versus 8.5% in the deactivated control group at three months. - The landmark prospective, multi-center, randomized FDA-approved IDE clinical trial provides Level I evidence and resulted in an FDA 510(k) expanded indication. - No serious adverse events were reported, and pain reduction benefits were sustained through 12 months of follow-up.