Class III Device Complete Solution

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Nova ScienceHemo-Stape

Hemo-Stape is an arterial closure device used to staple the common femoral arteriotomy. Hemo-Stape is used following diagnostic and interventional therapeutic endovascular procedures such as peripheral or coronary angiography, arterial stents and balloon angioplasty.

Benefit to Patient and Surgeon
Instant arterial closure and haemostasis by surgeons, post procedure results in reduced post-operative care and lower healthcare cost. Also, faster heal time return patients to full ambulation with added health and quality of life benefits.

Early human factors integration
Devices of this type can sometimes have confusing user interfaces leading to misuse and unintentional activation. An average of 12% of premarket approval applications are now rejected during the FDA process due to inadequate human factors engineering (HFE). With this in mind human factors engineering was integrated into the development process early. Our goal was to achieve a difficult balance between usability and device safety. To realise this goal we worked with a network of leading vascular specialists at the Royal College of Surgeon’s in Ireland and the ergonomics department at the University of California.

Reduced time-to-market
HFE parameters were tested throughout the development process. The project team worked closely to merge mechanical and human factor’s requirements. This maximised safety while minimising risk. The decision to conduct formative and verification human factors testing early in the process reduced human factors related device error and failure. Simulated human factors validation was also carried out in surgical environments reducing development cost and time-to-market

Successful human trials
Following animal and cadaver trials, the device proved to be highly successful through human trials and a comprehensive HFE verification and validation report by Design Partners formed part of Nova Science’s submission for FDA premarket approval.


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