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Ed. Note: The following
story is a press release from Confluent Surgical, Inc. April
7, 2005 Confluent
Surgical, Inc. announced today that the U.S Food and Drug Administration
(FDA) has approved the DuraSeal™ Dural Sealant System as the first and
only product indicated as an adjunct to sutured dural repair during
cranial surgery to achieve watertight closure. The FDA has approved the
DuraSeal Sealant with a condition to conduct a post-approval study.
The DuraSeal technology is a patented synthetic, absorbable hydrogel
delivered by a dual syringe applicator. The device can be stored at room
temperature and prepared in less than two minutes. When sprayed on to the
dura, a strong, adherent sealing layer is produced and effectively seals
the suture line within seconds. A feature unique to the DuraSeal Sealant
is the blue colorant that provides the surgeon excellent visualization of
coverage and thickness of the material upon application to the dura.
Postoperatively, the DuraSeal Sealant continues to seal the suture line as
healing progresses under the gel. After several weeks, the hydrogel breaks
down into water-soluble molecules that are absorbed and cleared through
the kidneys. Clinical results presented to the FDA demonstrated the
DuraSeal Sealant was able to achieve watertight closure in 98% of cases,
immediate sealing was obtained on the first application in 95% of cases,
and 95% of applications were rated as “easy” to “very easy” by
neurosurgeons using the product.
“Watertight closure of the dura has to date been an elusive goal. With
DuraSeal, it can become a reality. This sealant is easy to apply, really
works and has the potential for providing a new paradigm for how the dura
is closed following cranial surgery. I’m confident it will have a profound
effect on my cranial procedures”, said Harry van Loveren, MD, chairman of
the Department of Neurosurgery, Universtiy of South Florida, and a
principal investigator in the pivotal DuraSeal multi-center study.
“We have seen a tremendous reception for DuraSeal internationally and we
are looking forward to making it a commercial success in the United
States” said Amar Sawhney, Co-Founder, President & CEO of Confluent
Surgical.
“This is a remarkable product and as the first and only FDA approved dural
sealant product, I look forward to using DuraSeal for achieving a
watertight dural closure”, said G. Rees Cosgrove, MD, Associate Professor
of Surgery, Harvard Medical School, and the Lahey Clinic.
There are approximately 250,000 craniotomies performed in the U.S each
year and almost all cases involve a suture repair of the dura. Confluent
Surgical has established an extensive and distinguished neurosurgeon
focused distribution channel to represent the DuraSeal product in the U.S.
market.
Confluent Surgical is a private medical device company that is pioneering
the development of in-situ-polymerized biomaterials. The synthetic
materials are safe, simple to use, and allow the formation of customized
implants at the site of disease. These materials have potentially numerous
applications across several surgical disciplines.
For additional information, visit the Confluent Surgical and DuraSeal
website at
http://www.confluentsurgical.com/ and
http://www.duralsealant.com/
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