Pacira BioSciences Secures FDA Approval For New Iovera SmartTip to Manage Chronic Low Back Pain
Pacira BioSciences Secures FDA Approval For New Iovera SmartTip to Manage Chronic Low Back Pain
On Tuesday, Pacira BioSciences, Inc. (NASDAQ:PCRX) received FDA clearance to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain.
周二，Pacira BioSciences, Inc. (纳斯达克:PCRX) 获得FDA批准，推出一种新的智能尖端，旨在访问中间支神经以管理慢性下背痛。
The ioverao system is a drug-free treatment that relieves pain via cryoneurolysis—a process whereby focused cold therapy is applied to a targeted nerve, temporarily interrupting its ability to transmit pain signals.
ioverao系统是一种无药物治疗，通过冷神经解冻来缓解疼痛，这是一种将集中冷疗应用于特定神经的过程，暂时中断其传递疼痛信号的能力。
Pain relief is typically experienced immediately after treatment, lasting for months as the nerve regenerates.
通常在治疗后立即体验到疼痛缓解，持续数月，直到神经再生。
Also Read: Pain Management-Focused Pacira BioSciences Loses Patent Fight For Key Drug, JP Morgan Analyst Downgrades On Unclear Path
另请阅读：以疼痛管理为重点的Pacira BioSciences在关键药物的专利争夺中败诉，摩根大通分析师因路径不明确而下调评级。
To date, the ioverao portfolio has consisted of either a three-pronged Smart Tip featuring 8.5-mm long 27-gauge needles to treat superficial nerves or a single, 90-mm long, 20-guage Smart Tip ideally suited to treat deeper nerves.
截至目前，ioverao产品组合包括一个三叉的智能尖端，使用8.5毫米长的27号针治疗表层神经，或一个单一的90毫米长的20号智能尖端，特别适合治疗更深层神经。
It is most commonly used to treat knee pain but frequently used to manage pain in the hip, shoulder, chest, foot & ankle, and more.
该器械最常用于治疗膝盖疼痛，但也常用于管理髋部、肩部、胸部、脚和脚踝等部位的疼痛。
This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve. It is specifically designed to relieve chronic low back pain associated with facet-mediated pain.
这种新的25号180毫米智能尖端将允许治疗更深层的神经，例如中间支神经。它特别设计用于缓解与椎间关节相关的慢性下背痛。
This longer-needle Smart Tip is designed for use through a cannula or introducer, allowing ice ball formation at deeper peripheral nerves.
这种较长针头的智能尖端设计用于通过套管或引导器使用，允许在更深的周围神经形成冰球。
Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures.
每年，2800万到3000万美国人寻求慢性背痛的治疗，但只有200万到300万接受介入治疗。
With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care.
随着新型iovera° Smart Tip的推出，Pacira旨在解决这些空白并提高护理标准。
The company adds that the product offers an alternative to conventional treatments, such as radiofrequency ablation, with substantial limitations.
该公司补充说，该产品为常规治疗方法（如射频消融）提供了一种替代方案，而常规治疗有相当大的局限性。
A single-center randomized pilot study of the iovera° system showed:
关于iovera°系统的单中心随机试点研究显示：
- Patients treated with iovera° reported pain scores more than 2 points lower at 180 and 360 days than those treated with RFA on the 0-10 NRS Pain scale.
- At 360 days, patients in the iovera° group showed statistically and clinically significant improvements in functional outcomes, as evidenced by average Oswestry Disability Index (ODI) scores improving from moderate to minimal disability.
- More iovera° patients expressed satisfaction with their pain management compared to those receiving RFA.
- No serious adverse events were observed over the course of the study.
- 接受iovera°治疗的患者在180天和360天时的疼痛评分比接受RFA治疗的患者低超过2分，使用的是0-10 NRS疼痛评分标准。
- 在360天时，iovera°组的患者在功能成果上显示出统计学和临床上的显著改善，平均Oswestry残疾指数（ODI）评分从中度残疾改善到轻度残疾。
- 与接受RFA治疗的患者相比，更多的iovera°患者对他们的疼痛管理表示满意。
- 在研究过程中未观察到严重的不良事件。
Price Action: PCRX stock is up 1.50% at $18.91 at the last check Tuesday.
价格动态：PCRX股票在周二最后一次检查时上涨1.50%，报18.91美元。
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