NSE ALPHA™

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NSE ALPHA™ is your answer to avoid balloon slippage while achieving plaque modification in preparation for therapeutic devices

NSE (Novel Scoring Element) ALPHA™ scoring balloon has three "free-floating" nylon elements positioned on the outside of the balloon in order to retain flexibility.

Eliminates balloon slippage during inflation.
Precise dilation for a variety of lesion indications.
Triangular elements are 0.0155 inch in height creating plaque modification.
Avoiding dissections allows for the potential to complete treatment using a stentless PCI strategy.

Specifications

Tip entry profile: 0.0167"
Balloon length: 13 mm
Balloon diameter: 2.0/2.25/2.5/2.75
3.0/3.25/3.5/4.0 mm
Normal pressure: 6 atm
Rated pressure: 14 atm
Element material: Nylon
Number of elements: 3
Element height: 0.155" (0.39 mm)

Double marker
Hydrophillic coating

Compliance chart

Inflation Pressure		Balloon Diameter (mm)
atm	kPa	2.00mm	2.25mm	2.50mm	2.75mm	3.00mm	3.25mm	3.50mm	4.00mm
4	4x10²	1.87	2.14	2.32	2.51	2.69	3.02	3.16	3.58
5	5x10²	1.91	2.18	2.38	2.56	2.75	3.08	3.24	3.67
6 (NP)	6x10²	1.95	2.22	2.44	2.60	2.82	3.14	3.32	3.77
7	7x10²	1.99	2.26	2.50	2.66	2.88	3.20	3.39	3.86
8	8x10²	2.03	2.30	2.55	2.70	2.94	3.25	3.46	3.94
9	9x10²	2.06	2.34	2.60	2.74	2.98	3.30	3.52	4.02
10	10x10²	2.09	2.38	2.64	2.78	3.03	3.33	3.55	4.07
11	11x10²	2.12	2.41	2.67	2.81	3.06	3.36	3.60	4.12
12	12x10²	2.16	2.44	2.70	2.84	3.10	3.38	3.64	4.15
13	13x10²	2.19	2.46	2.72	2.86	3.13	3.41	3.67	4.19
14 (RBP)	14x10²	2.21	2.49	2.75	2.88	3.15	3.43	3.70	4.22
15	15x10²	2.24	2.51	2.76	2.91	3.17	3.46	3.73	4.25
16	16x10²	2.27	2.53	2.79	2.93	3.20	3.48	3.76	4.28

Frequently Asked Questions (FAQs)

How is NSE Alpha superior compared to other commercial devices ?

The working height of the 3 elements are set higher than CB and other scoring balloons providing for a better scoring effect. The larger surface area of the base of the elements reduces the amount of balloon resistance when coming into contact with hard plaque, increasing the push transmission to the apex of the elements. An additional benefit of being made from a nylon material allows for a greater conformable expansion in a tortuous vessel. Appropriate size selection reduces risk of perforation.

Can NSE ALPHA be used for post stent inflation? Does this potentially cause damage to the elements?

In Japan (with the greatest usage of NSE in the world), there are facilities that use NSE for post-stent inflation due to insurance limitations (limited by the number of balloons that can be used in a single procedure). The apex of the element (that comes into contact with the stent strut) may incur a slight indentation to the nylon material but there have been no reports of any element detachment and is not considered a concern.

Is there potential to incur damage or breakage to the elements during use in severely calcified lesion, or at high inflation pressures?

Although the elements are made of nylon, even at RBP (Rated Burst Pressure) there is little crushing of the apex component of the element. Some distortion can be observed under a microscope, but it is not sufficient to cause any detrimental effect in a clinical setting.

How does a scoring balloon compare to standard angioplasty balloons?

Scoring balloons offer enhanced plaque modification capabilities compared to standard balloons, making them suitable for more challenging lesions.

What are the potential risks associated with using a scoring balloon?

Risks include vessel injury, dissection, or thrombosis, which are minimized with careful technique and under the guidance of experienced interventional cardiologists.

Are there different types of scoring balloons?

Yes, scoring balloons come in various designs and configurations, each suited for different lesion characteristics and procedural requirements.