A Multicentric, Randomized Controlled Trial To Assess The Performance And Safety Of Two Different Bone Flap Fixation Systems For Craniotomy Procedures

Last Wednesday May 17th, NEOS Surgery organized a webinar for the LATAM and
Spanish market focused on the clinical experience with Cranial LOOP at the Hospital
Universitario La Paz (Madrid, Spain). This hospital is a reference center in the country
and It has recently been included in the list of the 100 best hospitals in the world (1).
On this occasion, we had the great opportunity to have the participation of Dr. Gómez de
la Riva, neurosurgeon from the hospital specialized in vascular surgery, with more than
four years of experience using Cranial LOOP for closing craniotomies.
Dr. Gómez de la Riva shared his clinical experience on cranial fixation systems and
presented some clinical cases highlighting the benefits that Cranial LOOP provides
in his usual clinical practice.
We highlight:
- More than 100 implanted cases: He decided to use Cranial LOOP products when
experiencing difficulties in the re-operation of patients who had been closed with metallic
cranial fixation systems. - He used Cranial LOOP, above all, in any type of supratentorial craniotomies
regardless of the pathology. He didn’t use it in custom cranioplasties or skull fractures. - The closure is very stable with 3 products equally distributed throughout the
craniotomy. Solid bone fixation and good alignment of the bone flap is obtained. - The product presents a minimal and homogeneous profile. It has better aesthetic
results compared to titanium plates, especially in the pterional area. He has stopped
receiving complaints from patients about the presence of the cranial closure when
palpated. - Regarding safety, there have been no failures or complications with the product.
Absence of hematoma (referring to epidural bleeding) or cases of infection. He has not
had to re-operate any patient for reasons related to the device. - Cranial LOOP is a simple and easy system. It provides a solid and reliable closure,
achieving good bone fixation. Minimal manipulation of the bone flap is required compared
when using titanium plates and It has excellent cosmetic results.
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