Navigation Links
Insightra Medical, Inc. Gains FDA clearance for the Most Complete Range of 7Fr Intra Aortic Balloon (IAB) Catheters
Date:1/19/2009

Insightra Medical announced 510(k) clearance of their full range of 7Fr IAB catheters and immediate release in the United States.

Irvine, CA (PRWEB) January 19, 2009 -- Insightra Medical Inc., a privately held medical device company based in Irvine, California, markets the most complete range of 7Fr IAB catheters in sizes including: 40cc, 35cc, 30cc, 25cc and 20cc, all in a true 7Fr diameter.

"We want to offer customers product flexibility and a very high level of quality," says Brad Sharp, CEO of Insightra. "The market seems to agree that 7Fr is a big improvement in terms of distal flow, comfort and safety. The key is to deliver that 7Fr benefit to the entire population, and not just those who fit the most popular sizes. That is why we have brought such a complete offering to market."

The balloon catheter already has CE mark approval and is selling globally; the addition of FDA clearance allows Insightra to bring the benefits of this offering to the United States, the largest market for IAB catheters.

The patented 7Fr catheter design is the largest range of that size which utilizes a standard fluid filled core, a proven technology in IAB pumping. This key feature means the catheters can be used on virtually any older model of balloon pump, while being fully compatible with the latest balloon pumps on the market (1). By being broadly compatible, hospitals are not required to upgrade their older machines to newer fiber-optic consoles; a huge cost saving.

The balloon at the heart of the kit has been used in Japan for over 8 years on a wide variety of machines and has clinically demonstrated to perform as well as an 8Fr balloon, even with difficult tachycardia patients. The balloon, which was one of the first to be incorporated into a 7Fr design, has a long track record of clinical use.

The catheter was designed from the ground up to be 7Fr, not an adaption of an 8Fr technology. The shaft of the catheter is thin, but strong, and provides a large central lumen, comparable to most 8Fr catheters. This translates to excellent gas shuttling plus an 0.028" central fluid lumen, which allows for reliable pressure monitoring and the use of a larger 0.025" guidewire.

A combination of catheter technology, unique balloon extrusion and folding techniques means the Insightra 7Fr catheter is a true 7Fr and will fit down all 7Fr sheaths routinely available in the cath lab.

"Despite the fact that IAB technology is not new, the Insightra line really provides a surprising number of meaningful benefits," says Steve Bell, President of Insightra Medical. "To be able to have such a wide range of sizes in true 7Fr without the need for new hardware is a big advantage to customers; especially in terms of immediately offering 7Fr therapy to a broader range of patients."

Being a life-sustaining product, quality is paramount for the Insightra IAB catheter. That is why every single catheter undergoes a rigorous quality inspection that tests the catheter through 50,000 cycles to ensure that every device is of the highest quality before it reaches the customer. This combined with the propriety extrusion of the ultra-strong balloon gives an incredibly low rupture rate (2)(3) even with prolonged pumping (4).

The Insightra Ultra 7Fr IAB catheters are available now. For your local distributor contact sales(at)insightra(dot)com.

Insightra Medical (http://www.insightra.com) is a device incubator that brings early stage technology to market, sells the product as an Insightra branded product, or spins the technology into a new company for further funding. At present the company has two products launched globally with three more due to launch by Q3-09. Areas of focus include surgical retraction, hernia repair, urinary incontinence, and natural orifice surgery (Minos Medical).

(1)   Compatibility table on file
(2)   Comparative Study of Five Types of IABP balloons in terms of incidence of balloon rupture and other complications: A multi institutional study
Nishida et al : Artificial organs 18(10) 746-751 1994
(3)   Our experience with a new 7Fr IAB and a performance comparison with another device and drive machine: Matsuda et al JPN J Interv Cardiol 2006 21: 82-87
(4)   Prolonged Use for at Least 10 Days of Intraaortic Balloon Pumping (IABP) for Heart Failure Kiyohiro et al Intl Heart J Vol46 No 6 November 2005

# # #

Read the full story at http://www.prweb.com/releases/7friabp/insightra/prweb1883344.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. NTU and Insightra Medical Inc. release their first joint venture medical device
2. China Sky One Medical, Inc. Provides Business Update
3. Thermage, Inc. Announces Name Change to Solta Medical, Inc.
4. China Sky One Medical, Inc. Obtains Production Rights for Two Additional Drugs
5. "The Economic Report" Show to Feature Gradient Medical, LLC
6. China Sky One Medical, Inc. Obtains Production Rights for Two New Drugs
7. China Sky One Medical, Inc. Appoints Yu-bo Hao as CFO
8. CPC Launches New Web Site Highlighting Medical, Research and Technical Panel, MedClose(TM) VCS Animated Video
9. China Sky One Medical, Inc. Announces Record Third Quarter 2008 Results
10. Vertos Medical, Inc. Appoints James M. Corbett Chief Executive Officer
11. Interview with Dr. Elisabeth Hager, CEO of Balan Biomedical, Inc., to Air Nationally on Sky Radio
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Insightra Medical, Inc. Gains FDA clearance for the Most Complete Range of 7Fr Intra Aortic Balloon (IAB) Catheters 
(Date:3/29/2017)... ... ... Youth Futures International (YFI) premiered its Serve, Learn, & Empower program in 2009 ... have participated in the program every summer. The 2017 Serve, Learn, & Empower ... Visit http://www.ghana.yfiexperience.org to learn more. , “I have sent my daughter ...
(Date:3/29/2017)... ... March 30, 2017 , ... Sports Brand EXOUS Bodygear announced today ... normally at $29.97; for the remaining days of March, the price will be only ... a special price of just $10 (regular retail price $19.97). , The special promotional ...
(Date:3/29/2017)... Rouge, Louisiana (PRWEB) , ... March 29, 2017 ... ... HeartBoost in three Hours at a Walgreens store in Mississippi. AngioGenesis Labs, makers ... at Walgreens Stores in two southeastern states. Ingredients in HeartBoost, an over the ...
(Date:3/29/2017)... (PRWEB) , ... March 29, 2017 , ... ... this webinar provides insight into the challenges employers face in trying to balance ... of managing employee benefits programs? Adding to the growing complexity, companies are ...
(Date:3/29/2017)... ... 29, 2017 , ... Dr. Angela Cotey, a noted general dentist in Mt. ... patients, with or without a referral. Dr. Cotey knows that interceptive orthodontics ... experience. When patients receive early treatment, they may achieve straight teeth with less treatment ...
Breaking Medicine News(10 mins):
(Date:3/29/2017)... March 29, 2017 Transparency ... which provides an exhaustive study of the U.S. substance ... 242 companies are functional in this market at ... the leading companies, such as GlaxoSmithKline Plc., Pfizer ... aggressively on various marketing strategies to increase their ...
(Date:3/29/2017)... 2017 Research and Markets has announced the ... 2023" report to their offering. ... The ablation device global market is expected ... by 2023. Ablation is the minimally invasive therapeutic ... cancerous or diseased tissue removal, to the removal of abnormally conducting ...
(Date:3/29/2017)... 29, 2017   Dynatronics Corporation (NASDAQ: ... of Cynthia L. McHenry (Cyndi) as ... for leading Dynatronics manufacturing, distribution, and purchasing operations ... Dynatronics, CEO Kelvyn H. Cullimore, Jr. ... search process conducted by the company as it ...
Breaking Medicine Technology: