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.
週二，Pacira BioSciences, Inc. (納斯達克:PCRX) 獲得FDA批准，推出一種新的智能尖端，旨在訪問中間支神經以管理慢性下背痛。
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系統是一種無藥物治療，通過冷神經解凍來緩解疼痛，這是一種將集中冷療應用於特定神經的過程，暫時中斷其傳遞疼痛信號的能力。
Pain relief is typically experienced immediately after treatment, lasting for months as the nerve regenerates.
通常在治療後立即體驗到疼痛緩解，持續數月，直到神經再生。
Also Read: Pain Management-Focused Pacira BioSciences Loses Patent Fight For Key Drug, JP Morgan Analyst Downgrades On Unclear Path
另請閱讀：以疼痛管理爲重點的Pacira BioSciences在關鍵藥物的專利爭奪中敗訴，摩根大通分析師因路徑不明確而下調評級。
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產品組合包括一個三叉的智能尖端，使用8.5毫米長的27號針治療表層神經，或一個單一的90毫米長的20號智能尖端，特別適合治療更深層神經。
It is most commonly used to treat knee pain but frequently used to manage pain in the hip, shoulder, chest, foot & ankle, and more.
該器械最常用於治療膝蓋疼痛，但也常用於管理髖部、肩部、胸部、腳和腳踝等部位的疼痛。
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.
這種新的25號180毫米智能尖端將允許治療更深層的神經，例如中間支神經。它特別設計用於緩解與椎間關節相關的慢性下背痛。
This longer-needle Smart Tip is designed for use through a cannula or introducer, allowing ice ball formation at deeper peripheral nerves.
這種較長針頭的智能尖端設計用於通過套管或引導器使用，允許在更深的周圍神經形成冰球。
Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures.
每年，2800萬到3000萬美國人尋求慢性背痛的治療，但只有200萬到300萬接受介入治療。
With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care.
隨着新型iovera° Smart Tip的推出，Pacira旨在解決這些空白並提高護理標準。
The company adds that the product offers an alternative to conventional treatments, such as radiofrequency ablation, with substantial limitations.
該公司補充說，該產品爲常規治療方法（如射頻消融）提供了一種替代方案，而常規治療有相當大的侷限性。
A single-center randomized pilot study of the iovera° system showed:
關於iovera°系統的單中心隨機試點研究顯示：
- 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°治療的患者在180天和360天時的疼痛評分比接受RFA治療的患者低超過2分，使用的是0-10 NRS疼痛評分標準。
- 在360天時，iovera°組的患者在功能成果上顯示出統計學和臨牀上的顯著改善，平均Oswestry殘疾指數（ODI）評分從中度殘疾改善到輕度殘疾。
- 與接受RFA治療的患者相比，更多的iovera°患者對他們的疼痛管理表示滿意。
- 在研究過程中未觀察到嚴重的不良事件。
Price Action: PCRX stock is up 1.50% at $18.91 at the last check Tuesday.
價格動態：PCRX股票在週二最後一次檢查時上漲1.50%，報18.91美元。
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譯文內容由第三人軟體翻譯。
