Clinical

The Zip™ Surgical Skin Closure devices are Class I, 510(k) Exempt1 devices. Several post-market studies are underway at hospitals and private clinics in the United States to further evaluate device attributes. Please contact ZipLine Medical for further information on these studies.

 

Pre-Clinical Studies

Pre-clinical studies have been conducted to evaluate device performance as compared to traditional closure techniques such as sutures.  The following illustrates preliminary results from some of these studies.

Preclinical feasibility testing of the ZipLine technology using a chronic porcine model was conducted in 2010 (data on file).  Surgical incisions were closed either with the ZipLine technology, or absorbable subcuticular sutures.  Devices were removed at two weeks post-operatively, and resulting scars were evaluated at 6-weeks by a blinded panel of four board-certified plastic surgeons.  Results revealed excellent cosmesis when compared to subcuticular suture controls.

Below is an example of comparative outcomes at 6-weeks:

 

Preclinical Zip1 Preclinical control

ZipLine Closure

Subcuticular Suture Closure

 

The Cosmetic Visual Analog Scale (CVAS) and ordinal Wound Evaluation Scale (WES) were used to evaluate photographs of each scar from the test subjects.  Evaluators were blinded to the type of closure method used for each wound. 

 

 Surgical Incision Closure (10cm)

 

Closure Mechanism

Avg WES

Avg CVAS

Subject 1

Controls, n=2

5.25

83.5

ZipLine 10cm, n=4

5.95

92.75

Subject 2

Controls, n=2

5.90

84.5

ZipLine 10cm, n=4

5.95

93.0

 

Skin Excision Closure (3cm)

 

Closure Mechanism

Avg WES

Avg CVAS

Subject 1

Controls, n=2

5.55

89

ZipLine excision, n=1

6.00

88

Subject 2

Controls, n=1

5.50

89

ZipLine excision, n=1

6.00

88

 

These results suggest that incisions and excisions closed using ZipLine technology can result in at least equivalent cosmesis when compared to suture closure. 

 

Histology

Histological analysis was performed on sample scars from both test and control groups.

Surgical Incision Closure (10cm)

histology_suture_control histology_zip1

Subcuticular Suture Closure

ZipLine Closure

 

Skin Excision Closure (3cm)

histology_excision_suture_control histology_zip2

Subcuticular Suture Closure

ZipLine Closure

 

H&E staining was performed on representative cross-sections of incisions closed with traditional suture techniques vs. the ZipLine device.  The width and depth of the resulting scars as well as the degree of local inflammatory response were evaluated by a blinded pathologist.  The degrees of scarring and inflammation were deemed to be qualitatively equivalent between the two groups.

 

1 The ZipLine devices are classified by the U.S. FDA as ‘Class 1, Exempt’. The Company has confirmation of FDA determination of this classification on file.