Abbott  announced that the FDA has approved an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System to evaluate the treatment of severe calcification in coronary arteries prior to stenting

Abbott 宣布 FDA 已批准其冠状动脉血管内碎石术 (IVL) 系统的研究设备豁免 (IDE)，以评估在支架置入前治疗冠状动脉严重钙化的效果。

The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the U.S.

TECTONIC冠状动脉疾病（CAD）血管内碎石术（IVL）临床试验将在美国的47个地点招募多达335人。

Currently, physicians often use several therapy approaches to clear calcified arterial blockages, including cutting balloons and atherectomy technology. Intravascular Lithotripsy ( IVL )is a newer treatment for calcified coronary arteries that treats blockages by fracturing the calcium within the artery wall, potentially allowing for vessel expansion and better stent placement.

目前，医生通常会使用多种治疗方法来清除钙化的动脉阻塞，包括切割球囊和动脉粥样硬化切除技术。血管内碎石术 (IVL) 是一种较新的治疗钙化冠状动脉的方法，通过破碎动脉壁内的钙化物来治疗阻塞，可能有助于血管扩张和更好地放置支架。

Abbott's investigational Coronary IVL System uses high-energy sound pressure waves to treat calcium blockages prior to placing a stent..

Abbott公司的研究性冠状动脉冲击波碎石术系统利用高能量声压波在放置支架之前治疗钙化堵塞。

'For people living with coronary artery disease, severe calcification can make treatment more challenging, often limiting the effectiveness of standard interventions like angioplasty or stenting,' said Eric Secemsky, M.D., director of vascular intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center in Boston, MA and co-principal investigator for the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial.

“对于冠状动脉疾病患者来说，严重的钙化会使治疗更具挑战性，常常限制了如血管成形术或支架置入等标准干预措施的效果，”波士顿麻萨诸塞州贝斯以色列女执事医疗中心心血管研究所血管介入主任、TECTONIC冠状动脉疾病（CAD）血管内碎石术（IVL）试验的共同首席研究员埃里克·塞森斯基（Eric Secemsky）博士说道。

'The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement.'.

‘TECTONIC冠状动脉疾病（CAD）血管内碎石术（IVL）试验将评估一种可能的新治疗选项，用于在支架置入前准备血管并优化支架放置。’

'Abbott is a leader in treating coronary artery disease, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. Through our expansive portfolio of treatment offerings, we aim to make interventions safer and more effective for people who need them most,' said Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott's vascular business.

“Abbott在治疗冠状动脉疾病方面处于领先地位，在每个阶段都提供最佳的诊断和治疗选择以检测和处理钙化问题。通过我们广泛的治疗产品组合，我们旨在为最需要干预的患者提供更安全、更有效的治疗方案，” Abbott血管业务全球临床事务部门副总裁Jennifer Jones-McMeans博士表示。

'Now, by working with physicians to evaluate Abbott's Coronary IVL System, we are exploring the next generation of calcium modification technology, advancing our portfolio of treatments for coronary artery disease.'.

“现在，通过与医生合作评估雅培的冠状动脉冲击波碎石系统，我们正在探索下一代钙化处理技术，推进我们治疗冠状动脉疾病的方案组合。”

Abbott's Coronary Intravascular Lithotripsy (IVL) system is an investigational device and not commercially available.

雅培的冠状动脉血管内碎石术（IVL）系统是一种研究性设备，尚未商业上市。

Condition:

条件：

Coronary Artery Disease/Calcified Lesions

冠状动脉疾病/钙化病变

Type:

类型：

drug

药物