相关临床试验
3
2 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
33.3%
Enrolling By Invitation
1
33.3%
招募中
1
33.3%
暂无批准数据
- Gradient Denervation Technologies' novel ultrasound-based pulmonary denervation system has received FDA Breakthrough Device Designation, creating an expedited review pathway for this potentially life-changing technology. - The system treats pulmonary hypertension by ablating nerves around the pulmonary artery using therapeutic ultrasound in a minimally invasive procedure, aiming to reduce vascular resistance and decrease pulmonary pressures. - The PreVail-PH2 Early Feasibility Study is currently enrolling patients with Group 2 Pulmonary Hypertension, a condition affecting up to two-thirds of heart failure patients worldwide with no currently approved therapies in the US.
- Gradient Denervation Technologies appointed Stanton Rowe, a medical device entrepreneur, to its board of directors to leverage his expertise in medical technology development. - The FDA approved the expansion of Gradient's PreVail-PH2 Early Feasibility Study for their ultrasound-based pulmonary artery denervation technology. - The study is enrolling patients with WHO Group 2 Pulmonary Hypertension at multiple centers in the United States to assess the safety and efficacy. - Gradient's minimally invasive device aims to provide a novel treatment option for pulmonary hypertension patients with associated heart failure, addressing an unmet need.
