subtitle text here zylon medical devices smaller is better supported by nih sbir phase ii grant # 5...
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Subtitle Text HereZylon Medical Devices
Smaller Is Better
Supported by NIH SBIR PHASE II Grant # 5 R44 H 68331-3
Subtitle Text Here
Angioplasty
Catheter Featuring
The “ZeroFold” Balloon
Overview
The Zylon® Angioplasty catheter with “ZeroFold” Balloon
Innovative cardiovascular deviceDeveloped to expand clinical application of percutaneous transluminal coronary angioplasty (PTCA)Based on patented technologyAngioplasty balloon catheter with “absolutely the lowest profile”Allows certain previously un-crossable or difficult-to-cross stenosed coronary arteries to be crossable and dilatable with efficacy and precision
Supported by NIH SBIR Phase II Grant # 5 R44 H 68331-3
The Problem
PTCA
Percutaneous Transluminal Coronary Angioplasty (PTCA)
Minimally invasive surgical approachFor treatment of coronary artery blockages
Stenosed artery
Current Catheters
Current Balloon CathetersAs typically used in PTCA procedures
Balloon is pre-sized, folded, wrapped and located at end of catheterCatheter is placed across a stenotic lesionUpon presserization, balloon unfolds to force open the stenosis
Crossing the Lesion
Crossing the LesionPhysician must be able to cross the lesion to dilate the stenosisAny increase in crossing resistance restricts clinical usefulness, especially in these procedures:
Small arteriesTight stenosesChronic Total Occlusion (CTO)
Surgery
Inability to Cross LesionConsigns patient to open heart surgery
Open heart surgery is effective, but characterized by:High morbidityHigh ExpenseLong recovery times
The Preferred treatment is the minimally invasive balloon angioplasty procedure
The Problem
Reducing the profile of the balloon in PTCA catheters
still remains clinically significant in interventional cardiology.
The Zylon® Solution
The Zylon® Solution
The Zylon® PTCA Catheter with ZeroFold Balloon
Based on patented technologyUtilizes a non folded balloonInflates to full size after crossing target stenosisEliminates the folded and wrapped balloon of current angioplasty catheters
The Zylon® Solution
Standard Catheter and BalloonFull size balloon attached to catheter shaftThen wrapped and folded to reduce profileCreates region of high cross resistance due to presence of multiple layers of wrapped and folded balloon material
The Zylon® Solution
Zylon® Catheter with Zero Fold Balloon
Balloon has NO wrapped or folded materialExhibits smooth, continuous transition from tip to proximal shaft“Absolutely the lowest profile” possible
The Zylon® Solution
InflationZylon® “ZeroFold” balloons inflate with predictable radial expansion characteristicsHigh burst strengthHigh flexibilityLow axial growth
The Zylon® Solution
Zylon® “ZeroFold” balloon vs. standard folded balloon
Zylon No-FoldBalloon Catheter
ConventionalBalloon Catheter
No FoldBalloon
FoldedBalloon
Inner Lumen
The Zylon Solution
Upper Catheter0.024” Hole Test
Fail- at distal fold
Zylon Catheter0.024” Hole Test
Pass- entire balloon
The Zylon Solution
Other advantagesImproved Pushability
Easier crossing, less resistance
FlexibleSmooth gentle inflationEasier to manufactureSimple, no retraining requiredSmaller* profile over entire range of coronary balloon catheter sizes (1.5-4.0*)
The Zylon Solution
ApplicationsCTO Pre-dilationPOBA (plain old balloon angioplasty)Stent delivery – lower profile with custom stentRx, over-the-wire, fixed wire versions
Intellectual Property
Intellectual Property
The following patents and patent applications have relevance to ZeroFold balloon technology:
US 5,900,444, Irradiation Conversion of Thermoplastic to Thermoset Polyurethane.US 6,596,818, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US 6,558,732, Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU.US 6,656,550, Dilatation device of uniform outer diameter.EP 0934007, Irradiation Conversion of Thermoplastic to Thermoset Polymers.Canada 2,267,684, Irradiation Conversion of Thermoplastic to Thermoset Polymers.IS129342, Irradiation Conversion of Thermoplastic to Thermoset Polymers.US 20030212318, Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU.US 20040002729, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US 20040093008, Reduced Profile Medical Balloon Element.
Intellectual Property
Trademarks
Zylon, US 2,174,478
Penetrator US 77315423
Irracure US 2,574,588
Fluorothane US 2,505,088
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Zylon Corporation600 Chestnut Ridge RoadChestnut Ridge, NY 10977