Vascular Closure Systems completes first-in-human clinical trial of the 6F and 7F FastSeal Vascular Access Closure System

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Vascular Closure Systems has announced the successful conclusion of phases I and II of the first-in-human clinical trial for its 6F and 7F FastSeal Bioabsorbable Vascular Access Closure System. Data have shown exceptional time to haemostasis (TTH) and time to ambulation (TTA) in both phases of the clinical trial.  

The clinical trial included 10 patients in phase I and 20 in phase II with challenging anatomy and vessel condition. The company stated that the patient comfort with the system was excellent, with no groin pain during the deployment of the sealing element, immediately after, and throughout the vessel healing process. The post deployment follow-up evaluation (including echo doppler) confirmed normal vessel healing, without inflammation, and complete absorption of the FastSeal sealing element.

Alessandro Bortone and Emanuela de Cillis of the Policlinico di Bari, University of Bari School of Medicine, Italy, performed the procedures in both phases of the trial.


The FIH clinical trial results are as follows:

Phase I (10 patients, all diagnostic cases)

 

 

 

 

TTH

 

 

 

TTA

     

(min:sec)

     

(hrs:min)

Time

   

1:13

     

6:40 Hrs.

 

Std. Dev.

   

0:40

     

2:44

 

 

Phase II (20 patients total, 15 PCI cases)

 

     

TTH

     

TTA

     

(min:sec)

     

(hrs:min)

Time

   

0:43

     

2:14 Hrs.

 

Std. Dev.

   

0:34

     

1:07

             

 

The detailed phase I and phase II clinical trial results will be presented at multiple upcoming medical conferences, the company announced.


Vascular Closure is planning to begin international commercialisation (outside the USA, pending regulatory approval) of the 6F and 7F system during the second quarter of 2013.

About the FastSeal Bioabsorbable Vascular Access Closure System


The FastSeal Bioabsorbable Vascular Access Closure System is intended for use following a diagnostic or therapeutic, interventional cardiology or interventional radiology procedure. The system is packaged and used as a single piece unit, with no assembly required prior to use, and no separate deployment device is needed to be inserted into the puncture site. The system design enables haemostasis within less than a minute after the non-collagen sealing element has been deployed.


The system does not require the use of a specific type or brand of vascular introducer sheath, and is compatible with any commercialised vascular introducer sheath with a useable length of between 10 to 12cm (such as Cordis, St Jude Medical, Terumo, etc). Once the sealing element has been deployed, no external compression is required. The inner vessel section of the sealing element is absorbed within 10 to 14 days. The remainder of the sealing element is completely absorbed within 21 days. The FastSeal system has the ability to be removed after being deployed (if desired), without causing trauma to the vessel or requiring a surgical intervention. 

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