Vitrolife has received approval from the American Food and Drug Administration, so-called 510(k) clearance, for its new needle for the collection of human oocytes, Swemed Sense (patent pending), which reduces the risk of tissue damage and pain. The needle, which has previously received European approval, a so-called CE mark, and which was launched at ESHRE in 2008, has received a very positive response and publicity. Swemed Sense will now be launched in the USA.
Swemed Sense combines the good properties of Vitrolife's previous needles with a new way of designing the front part and tip, so that the patient will experience less discomfort and so that the risk of bleeding is reduced. "This is the first product that applies a new technical principle for oocyte collection needles. We believe in this principle very much," says Anette Jäderberg, marketing director at Vitrolife.
The Swemed Sense oocyte aspiration needle is designed with a thinner front part and tip so as to minimize tissue damage, bleeding and pain. However, the rear part of the needle has a larger diameter. This makes the needle stable and therefore does not reduce the handling ability. Furthermore, the procedure is just as fast as when a thicker needle is used, which is not the case with uniformly thin needles. A patent application has been submitted for Swemed Sense in all major markets.
It is estimated that the market for Swemed Sense, which is used in the collection of oocytes for IVF, amounts to approximately 50 million Euros worldwide.