ifu
TAV8 Aortic Valvuloplasty Balloon Catheter
Making aortic valve dilation easy.
Unique.
Figure 8-shaped balloon is designed to lock into valve anatomy, limiting movement, reducing procedure/ischemic time
Safe.
Balloon shape maintained throughout inflation reduces likelihood of annular rupture
Effective.
Enhanced leaflet hyperextension without increasing the risk of annulus over-distension
Fast.
Rapid inflate/deflate times
The reduction of the bulb lengths provides procedural enhancements over the V8:
- The 4mm distal bulb segment minimizes balloon engagement of the LVOT and possibly limits conduction disturbances!
- 15%-20% less inflation volume decreases the time for inflation/deflation, accelerates procedure time, reducing ischemia.
- The TAV8’s 24mm shoulder-to-shoulder balloon length is 40% shorter than the shoulder-to-shoulder length of a 40mm cylindrical balloon.
And yet this change does not remove the V8 advantages:
- Mechanically locks into the valve anatomy making Rapid Ventricular Pacing optional in some clinical situations
- Permits bulb sizing that hyperextends the aortic leaflets into the sinus, increasing the change in aortic valve area, without increasing the risk of excessive dilatation of the aortic annulus.
Product Information
| Catheter Size | Nominal Inflation Volume (cc) | Bulbous Segments Dia | Waist Segment Diameter (mm ± 10%) | Minimum Sheath Compatibility | Guidewire Compatibility (OTW) |
| 17mm | 13 | 21.5mm | 17.0 | 12F (4.0mm) | 0.035" (0.89mm) |
| 19mm | 16 | 23.5mm | 19.0 | 12F (4.0mm) | 0.035" (0.89mm) |
| 21mm | 20 | 25.5mm | 21.0 | 12F (4.0mm) | 0.035" (0.89mm) |
| 23mm | 23 | 28mm | 23.0 | 12F (4.0mm) | 0.035" (0.89mm) |
Order Information
The TAV8 Aortic Valvuloplasty Balloon Catheter is available in the following sizes. For more information, or to place an order, please contact us.
| Catheter Size | SKU |
| 17mm/22mm | TAV8-1722 |
| 19mm/24mm | TAV8-1924 |
| 21mm/26mm | TAV8-2126 |
| 23mm/28mm | TAV8-2328 |
Instructions for Use
InterValve Medical, Inc. provides quick and easy access to product literature online as an alternative to printed documents. Below you will find physician Instructions for Use (IFU) for selected products. InterValve recommends that product IFUs be downloaded, printed, reviewed, and readily available for operator reference during procedures when using our devices.
Note: These documents may be revised from time to time, so please refer to this Web page for the most current version at the time of the procedure.
Copies will be provided at no additional cost within 7 calendar days of receiving the request or at the time of delivery of the product if so requested at the time of order.
Please contact InterValve Medical to request a printed paper copy of an IFU.
| Hours of Operation | Phone Number | Fax Number | ||
| United States | 8 am - 5 pm (Central Standard Time) |
952.303.3539 | 952.303.6310 | quality@intervalveinc.com |
| Europe | 8 am - 5 pm (Central European Time) |
+32 11 28 6966 | +32 11 28 6909 | quality@intervalveinc.com |
InterValve Instructions for Use are available in PDF (Portable Document Format). To view the IFUs, users may download Adobe® Reader®. It is free software you can use to view PDF files. http://get.adobe.com/reader/
V8™ Aortic Valvuloplasty Balloon Catheter IFUPDF | 3.6 MB