Page 15

Opmaak 1

Nitza Shoham, VP Clinical and Regulatory: “Our products must be reliable and meet 13 on. DEKRA has a great deal of knowledge in the medical field and knows the markets and the requirements. What’s more, its knowledge is always up to date. Hence, DEKRA can help us to accomplish our ambitious objectives.” Innovative techniques The patient is central at Valtech Cardio. “It’s all about people,” explains VP Clinical and Regulatory Nitza Shoham. “Our products must be reliable and meet the highest quality standards. We also work on innovative devices that will ease the surgical technic. Any heart operation involves risk. A minimally invasive procedure reduces those risks and increases the patient’s welfare. Our Cardioband is a good example. It is fixed to the base of the mitral valve using specially designed anchors. Instead of doing an open heart surgery, the Cardioband is introduced through the groin by means of an introducer sheath.” “That makes it less invasive so that the patient recovers faster,” Azulay adds. “For an optimum result the closure of the mitral valve leaflets can be optimised by band contraction, under the view of an ultrasound device. The leakage from the mitral valve is then regulated and minimised.” High regard Valtech Cardio is a very advanced company that is highly regarded in the medical world. Arjan Knipmeijer, Project Manager at DEKRA: “The products make an important contribution to healthcare. I myself have undergone a number of heart operations in the past. I would have been pleased if the doctors at that time had been able to use Valtech Cardio products. The company is a pioneer in terms of innovative developments. The Cardioband is a ground-breaking product for this application, due to its minimally invasive introduction technique and the possibility of fine-tuning the system once it is in place. As an independent third party we not only assess the product testing, but are also involved in new developments. The aim of this is to draw up an appropriate plan for Valtech Cardio’s regulatory and clinical strategy early on in the process. On the basis of the technical information, we assess whether the medical device does what it is supposed to do for the prescribed use. During the validation phase of the development process we can discuss the clinical strategy for the new medical device with the customer if desired. We do that with an external clinical expert, usually an experienced doctor working at a Dutch teaching hospital. This method of operation enables Valtech Cardio to discuss the clinical strategy for the new medical device with clinical experts in the field – all at a very early stage.” Valtech Cardio has big ambitions. The company invests heavily in people and equipment. It works continuously on new products which offer even greater patient benefits. “One example is the minimally invasive introduction of a biovalve to replace the mitral valve. Valtech Cardio is a genuine leader in this area and counts among the top players in the field.” the highest quality standards” Arjan Knipmeijer, Project Manager at DEKRA: “Valtech Cardio has big ambitions”


Opmaak 1
To see the actual publication please follow the link above