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Javelin Medical Ltd.

27 Ha-Kidma street

2069201 Yokneam

Israel

Tel: +972 4 7701271

Fax: +972 4 770 1273

Email: avi@javelinmed.com

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The Vine™ filter – new concept for stroke prevention in atrial fibrillation (AF) patients

Vine™ is a permanent filter implanted in both common carotid arteries (CCAs) for stroke prevention in high-risk AF patients. Vine™ is designed to prevent proximally originating, clinically significant emboli from reaching the brain and causing a stroke. Vine™ comprises a single wire with circular cross-section that assumes a helical shape within the CCA. This shape is configured to capture emboli travelling up the CCA and prevent them from reaching the brain.

Stroke prevention in atrial fibrillation​

Stroke prevention in atrial fibrillation (AF) patients is an important medical need. In the United States, AF prevalence is > 6 million, with an incidence of 1.2 million cases per year (1). Nearly 800,000 Americans suffer from stroke each year (2), and one out of three of them is due to AF (3).  

Oral anticoagulants (OAC) reduce the stroke risk in AF patients. However, in patients treated with OAC and history of stroke, the annual ischemic stroke recurrence risk remains high at 2% - 3% (4-7). In AF patients, treated with OAC after acute stroke, the recurrence risk at 90 days and 1 year is >2% (8-10) and > 4%/year, respectively (11). 

 

 

Procedure

Vine™ is inserted in the CCA lumen through a thin (24 gauge) needle of the Vine™ inserter. The needle pierces through the skin of the neck and the CCA wall. Vine™ is automatically deployed from the Vine™ inserter upon activation of an operating button. Vine™ can be retrieved immediately and up to four hours post procedure. The procedure is performed by one operator under ultrasound imaging guidance and is completed within minutes.

Ultrasound probe

Vine™ inserter

A

B

A - Implantation procedure; B – Needle tip in CCA (ultrasound, transverse view)

Vine™ Embolic Protection System 

The Vine™ Embolic Protection System includes the Vine™ filter and the Vine™ inserter. Vine™ resides within the needle of the Vine™ inserter prior to use. The inserter includes a motor that deploys the Vine™ filter from the needle upon pressing an operating button.

Operatingbutton

Motor

Needle

Vine™ inserter

The Vine™ Filter

Vine™ is constructed from of super-elastic nitinol wire. It is capable of assuming a substantially linear shape in the un-deployed state (in the needle lumen), and a helical shape in the deployed state (in CCA). The helical shape includes a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filtering portion, and leading coils. The filtering portion has a cone shape facing upstream. After deployment, Vine™ is fixed in place by anchors (internal and external). 

Javelin Medical

Pulling wire

External anchor

Internal anchor

Helix

Supporting coils

Filtering portion

Leading coils

The Vine™

A

Stem

Supporting coils

Filtering portion

Leading coils

Helix

Direction of blood flow

B

Pulling wire

External anchor

Internal anchor

Vine™ in CCA: longitudinal (A) and transverse (B) views

References

  1. Colilla S.  Am J Cardiol 2013; 112: 1142 – 47. 

  2. Benjamin EJ.Circulation 2018; 137(12): e67 - e492.

  3. Yiin GSC. Stroke 2019; 50(1): 21-27. 

  4. Gundlund A.JAMA Netw Open. 2018; 1(1): e180171 (Danish cohort) 

  5. Diener. Lancet Neurol 2012; 11: 225 – 31. (AVERRORES)

  6. Easton.  Lancet Neurol 2012; 11: 503 – 11.(ARISTOTLE)  

  7. Hankey. Lancet Neurol 2012; 11: 315 – 22. (ROCKET AF)

  8. Wilson. J Neurol Neurosurg Psychiatry 2018; 0: 1 – 6.(CROMIS-2)

  9. Paciaroni. J Am Heart Assoc 2017; 6:e007034. (RAF-NOAC)

  10. Abdul-Rahim. Eu J Neurol 2015, 22: 1048 – 55. (VISTA)

  11. Yoshimura. Circ J 2018; 82: 1935 – 42. (SAMURAI-NVAF)