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这些独特的技术产品,

即拥有完整的知识产权保护,又有生产厂家的支持服务。我们为您提供中英文版本的介绍草案,中文部分请向下拖拉。


Technology licensing and IP rights Transfer Offer

The offer of these exclusive technology products featuring complete I.P. protection and producer support, are offered in English and Chinese. For Chinese please scroll down the page.


股骨导管插入仪

美国设计和工艺专利和批准,获美国食品和药物管理局批准,进入销售市场,目前主要销售对象为在美国本土开业的医生


femoral1


美国FDA(食品和药物管理局)批准并授予预置生物闭合(小肠黏膜下层,简称:“SIS”)介入式套管专利。该仪器用于导管插入术后,密闭股动脉的治疗。


早在2007年8月,该仪器即获得FDA的上市前许可(PMA)。 2008年7月,美国食品药品管理局清理了美国市场上在售的日益增多的式样繁复的产品。本产品在功效和销售领域均超越其他产品,成为当今市场中的佼佼者。


产品介绍

本产品独特的解决方案,改进了目前的护理标准。产品是一种血管闭合仪,应用于标准的导管插入手术过程中。本公司这项专有技术为医师们提供了动脉接入及闭合的生物治疗方案。帮助动脉完全重塑、促进愈合、抗疤痕和炎症,攻克了现有技术的最大局限。


心血管手术后,通常有两种方法闭合股动脉 – 人工挤压和血管闭合仪。


1. 人工挤压是由医护人员直接在患处用力推压30分钟,这常使病患疼痛异常,需要在医院恢复室的病床上休息很多小时。


2. 鉴于可以快速止血,医生们更多地会选用血管闭合仪(简称:VCD)以取代人工挤压术,使患者可以早日病愈出院,增加病患治疗数量,提高流动率。我们的仪器配有一个柔性的专利生物物质(简称:SIS),促进快速止血(动脉出血终止)和细胞重塑 – 帮助病患早日下地行走,早日出院。


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本公司研究了来自292位患者第一手大量资料得出临床结果证实,使用本仪器后,相比较人工挤压术而言,病患的止血时间明显下降,更早地下床行走,更早出院。随着实验室测试的大量增加的数据显示,术后30天,患者的不适没有明显的差别,不同于实施人工挤压术的患者。


本产品与现有的导管插入仪和组件普遍兼容。


采用独特生物技术的独效血管闭合仪

该产品的独特性在于,动脉穿刺部位,用获专利的生物可再吸收的细胞外基质(简称:ECM)填补。ECM,也就小肠黏膜下层(简称:SIS),这项独特的、经临床验证的生物材料专利技术,可进入血管壁将其完整重塑。对于目前的动脉切开术,或将外来物质留在血管穿刺部位来讲,是一个巨大进步。而这些外来物质会造成不必要的组织反应,限制再次接入,增加伤口感染的可能。相比之下,在动脉切开术时,使用SIS材料重塑技术,留下光滑地血管内皮,与人体的自身的免役系统一起工作,减少感染的风险。


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本公司认为本产品解决了当前血管闭合仪的的主要局限。本产品以单一套装出售,其中包含血管止血仪和介质。大大降低从导管插入实验室获取止血仪的时间。事实上,该止血仪被允许由先前接受导管插入手术地方的护士及技术人员移动使用。这种简化的过程有效地缓解医师资源,减化流程,为导管插入实验室节省了大量的财政支出。FISH™治疗仪还解决了在过程中被全盘逆转这一主要安全问题。


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产品的关键指标:


出色的临床结果

+ 保持血管完好 - 不堵塞血管或促其狭窄

+ 减少感染风险

+ 避免或减少病人的不适:无论是急性的或是慢性的

+ 全面提高病人满意度

+ 现有的血管止血仪中,最安全的产品

+ 能治疗更广泛的患者群(及最具挑战性的病患治疗组)



提升黄金标准

+ 在止血过程中,唯血管止血仪,所有功能整合在一个套装里

+ 普通常见和使用方法和流程,医生通过极简单的培训即可使用

+ 使病患早日下床行走,提高流动性,早日出院。更多的病患周转,整体降低去医院的成本 femoral6



知识产权

+ 公司已拥有一项专利,另五项正在申请中

+ 生物材料这项专利在交付和使用中,保证包括股动脉间在内的身体结构各组织之间完整独立

+ 依托强大的智力平台,为新产品广泛搜寻知识产权成果

+ 多样的设计元素和程序组件,其延续部分申请和新文件一直在审定中


可再吸收的栓塞专利

该产品独特在于,动脉穿刺部位,用获专利的生物可再吸收的细胞外基质(ECM)填补。ECM,也就小肠黏膜下层(SIS),这项独特的、经临床验证的生物材料专利技术,可进入血管壁将其百分百重塑。就目前动脉切开术,或将异物留在血管穿刺部位来讲,是巨大进步。

(详细的产品和技术信息见附件或网站链接:----------- 请选择)




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可用性:

+ 经FDA批准、领先的专利医疗设备的直接投资机会

+ 即刻获取技术的权利

+ 合作生产权


FISH™仪器使用程序/ /简单的三个步骤(并排放在表格的底部)



MOVIE - FISH animation English with Chinese subtitles / select to play


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插入 – 将套管插入体内,

触觉和视觉指示器,

确保SIS ®翻翘位置合适。


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调置 – 把翻翘调置在动脉壁后,释放线移除,

成为一独立的套管, SIS ®呈带状曝露在脉管里。



femoral6

压缩 - 一旦调整完毕,分开位于插孔底部的缝合符,

并拉回缝线,在血管壁上造一个SIS ®孔。套管移出后,

SIS ®即密合了动脉切开术的创口。


实用性:

+领先的专利医疗设备的直接投资机会

+即刻获取技术的权利

+合作生产权



如您对上述任何一个方案感兴趣,请按以下方式联系我们:

尖峰技术股份有限公司

沃尔那特北大街520号

印弟安那州布卢明顿市

邮编:47404


请洽:谢凯文 先生 / Kevin Jeffers

中国资产管理部 副总裁

电话:(812) 606-1550

传真:(812) 335-1961


信箱地址:

印弟安那州布卢明顿市

1772信箱

邮编:47402



Technology licensing and IP rights Transfer Offer

The offer of these exclusive technology products featuring complete I.P. protection and producer support, are offered in English and Chinese. For Chinese please scroll down the page.


Femoral catheterization device

U.S. Design and Process Patented and approved, U.S.A. Food and Drug Administration approved for sales and marketing, now sold to doctors practicing in the U.S.


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FDA (Food and Drug Administration) approved and Patented introducer sheath with a proprietary pre-mounted biologic closure (Small Intestinal Submucosa, “SIS”). The device is used to therapeutically seal the femoral artery following a catheterization proce­dure.


The device received Premarket Approval (PMA) from the FDA in August 2007. In July 2008, the FDA cleared the product for sale in the United States with multiple design enhancements. The product is now becoming a leader in the marketplace surpassing other products in efficacy and sales.


Product introduction:

The Product is a proprietary solution to improve the current standard of care. The Product is a vascular closure device used during a standard catheterization procedure. The Company’s proprietary technology provides physicians with a biologic healing application for arterial access and closure. This allows the artery to completely remodel itself, promoting healing, while resisting scarring and inflammation, which overcomes the greatest limitations of the current technology.


There are two methods of closing the femoral artery after cardiovascular procedures – manual compression and vascular closure devices.


1.Manual compression entails up to 30 minutes of firm physical pressure applied directly to the access site by attendants, which is often painful for the patient, followed by many hours of bed rest in a hospital recovery room.


2.Physicians frequently choose to use a vascular closure device (VCD) as an alternative to manual compression because it stops the bleeding more rapidly, thereby allowing patients to leave the hospital earlier and increas­ing patient throughput. Our device deploys a non-rigid proprietary biologic material (SIS) to the site of the artery, facilitating rapid hemosta­sis (cessation of arterial bleeding) and cell remodeling – resulting in earlier times to ambulation and discharge.


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Clinical results from the Company’s first large study of 292 patients demonstrated a significant decrease in time to hemostasis, time to ambulation, and time to discharge compared to the standard of manual compression. Along with the improvements in lab turnover times, there was also no significant difference in patient discom­fort at 30 days post-procedure, unlike comparable VCDs.


The Product is universally compatible with existing catheterization equipment and components.


An Effective VCD using Unique Biotechnology

The product is unique in its placement of a bio-resorbable extracellular matrix (ECM) at the site of the arterial puncture. This ECM, also known as small intestinal submucosal (SIS), is a patented, proprietary, clinically proven biologic material that is capable of completely remodeling into the arterial wall. This is a great advance from current devices that leave foreign material at the vascular puncture site, or arteriotomy. These foreign materials can cause unnecessary tissue reactions, limit re-access, and increase the likelihood of wound infection. In contrast, the remodeling of the SIS material leaves a smooth intravascular endothelium at the arteriotomy and works with the body’s natural defense mechanisms to reduce the risk of infection.



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The Company believes the Product addresses the major limitations of current VCDs. The Product utilizes a single sheath as both introducer and VCD. This significantly reduces the overall time required to achieve hemostasis in the catheterization lab and, in fact, allows the VCD to be removed by a nurse or technician in the post-catheterization holding area. This simplified process frees physician resources, expedites the procedure and can create significant financial savings to a catheterization lab. FISH™ also addresses a major safety issue by being completely reversible during the procedure.



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Brief key product points:


Superior Clinical Results

+ Maintains vessel integrity – does not occlude vessel or promote stenosis

+ Reduction in the risk of infection

+ Absence or reduction of patient discomfort: either acute or chronic

+ Overall improvement of patient satisfaction

+ Best safety profile among existing VCD’s

+ Able to treat a wider patient population (most challenging patient treatment groups)


Enhancement to the Gold Standard

+ Only VCD to integrate all-in-one sheath and closure procedure

+ Minimal physician training required – common practice and procedure

+ Allows for earlier time to ambulation, increased throughput and faster discharge from the hospital, resulting in higher patient turnover and a lower overall cost to the hospital



Intellectual Property

+ Company has been issued 1 patent, and has filed 5 follow-on applications.

+ Holds patent for the delivery and application of biologic materials to close the opening between body structures including the femoral artery

+ Wide reaching IP results in a strong intellectual platform for new products

+ Continuation-in-part applications and new filing for various design and procedure elements are under review femoral6


Patented reabsorbable Plug

The Product is unique in its placement of a patented bio-resorbable extracellular matrix (ECM) at the site of the arterial puncture. This ECM, also known as small intestinal submucosal (SIS), is a patented, proprietary, clinically proven biologic material that is capable of completely remodeling into the arterial wall. This is a great advance from current devices that leave foreign material at the vascular puncture site, or arteriotomy.

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The FISH™ Procedure

MOVIE - FISH animation English with Chinese subtitles / select to play


femoral6 Insertion - As the sheath enters the body, there are tactile and visual indicators to ensure the proper positioning of the SIS® cuff.

femoral6 Deployment – With the cuff at the artery wall, the release wire is removed, allowing the SIS® to become independent of the sheath while exposing the SIS® ribbon into the artery.

femoral6 Compression – Once deployed, detach the suture tab located on the bottom of the hub, and draw back the sutures to create a plug of SIS® at the vessel wall. Upon removal of the sheath, the SIS® seals the arteriotomy.


Availability:

+ Immediate investment opportunity in this leading FDA approved and patented medical device

+ Immediate access to technology rights

+ Co-operative production rights


If you are interested in one of these product offerings, contact us at the following address:


Pinnacle Technology LLC

520 North Walnut Street

Bloomington Indiana 47404


Attention: Kevin Jeffers

Vice President Asset Management / China

Phone number: (812) 606-1550

Fax number: (812) 335-1961


Mailing address:

P.O. Box 1772

Bloomington, In 47402

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