Dr Jim Norman is the most experienced parathyroid surgeon in the world and is the founder of the Norman Parathyroid Center--the largest parathyroid treatment center in the world. He and his team of expert surgeons perform more than 4000 parathyroid operations per year, more than 15 times the volume of any hospital or university in the world.
Dr Norman has seen hundreds of patients who have had their lives ruined by neck surgery--even when the surgeon's technique was near perfect. The nerves of the neck are amazingly sensitive, as are the tiny parathyroid glands. An operation that appeared to be performed perfectly often has problems postoperatively with laryngeal nerve paralysis and parathyroid dysfunction. Despite these problems being well known, there is no known way to mitigate their occurrence. Nothing is known to help.
Dr Norman is not alone in his desire to decrease these terrible but very common problems associated with nearly all forms of neck surgery. As he expanded his team to include other world-recognized experts and their surgical volume grew, he realized that a new approach was needed and the emerging field of biologics became the answer.
In 2016 Dr Norman had expanded his world-renowned parathyroid practice to become the nations highest volume thyroid surgery center and thyroid cancer treatment center by adding Dr Gary Clayman to his team. Dr Clayman was the Chief of Surgery and the Endowed Chair at MD Anderson Cancer Center in Houston for 17 years before leaving to join Dr Norman in Tampa. Dr Clayman founded the thyroid cancer program at MD Anderson, a program that he improved upon dramatically when given a clean slate in Tampa. Within 18 months of opening the Clayman Thyroid Center in Tampa, it has become the highest volume thyroid center in the US, far exceeding the program he left behind.
The full scale of endocrine surgery was realized with the addition of Dr Tobias Carling, the world's highest volume adrenal surgeon who was the Chief of Endocrine Surgery at Yale University prior to joining Jim in Tampa. Their center is now the leading endocrine center in the world, and 6 times larger than any hospital in the US.
Combined, these surgeons perform nearly 6,000 thyroid and parathyroid operations annually, and their team has the experience of over 70,000 thyroid and parathyroid operations performed. They have published more than 1200 peer-reviewed articles in major medical journals, and over 30 books or book chapters. In December 2021 Dr Norman and his team move into the new Hospital for Endocrine Surgery in Tampa, FL--a brand new facility built for surgery of the thyroid, parathyroid, and adrenal glands.
Dr Norman and his group are referred patients with a laryngeal nerve injury every single day. It is heartbreaking to see how a nerve (vocal cord nerve) injury affects their lives. When analyzing these injuries we notice that the surgeons dissect the nerve relatively early in the operation and then continue to operate for several more hours leaving the nerve vulnerable to injury via desiccation, traction, electrical impulse, friction, and direct trauma. Our nerve shield is specifically designed to help prevent injury to the recurrent nerve during the operation when the exposed nerve is vulnerable to trauma from surgical instruments, thermal injury, electrical injury, and desiccation.
With over 6000 thyroid and parathyroid operations performed annually by 10 surgeons, we have thousands of dissected and exposed recurrent laryngeal nerves every year -- more than a dozen every day. We were looking for several years to design a product that would protect the nerve during the operation. The amniotic nerve shield provides this protection but this is only a small part of the overall benefit.
Two prospective clinical trials have shown significantly faster return of recurrent laryngeal nerve function with amniotic membrane overlays. The first, conducted at Yale University departments of surgery and endocrine surgery showed the incidence of overall post op nerve injury to be slightly decreased. But more impressive was the fact that patients who did suffer a nerve injury and were treated with the amniotic membrane regained normal nerve function more than twice as fast as those who did not. Published Article
A second prospective clinical trial at the Norman/Clayman Endocrine Institute in 100 consecutive patients operated on by the highest volume thyroid surgeons in the US showed a decrease in the overall incidence of nerve injury from 8% to 4.5%. Like the results seen in the Yale study, patients who did have a laryngeal nerve injury recovered their voice and normal laryngeal nerve function on average more than twice as fast as those that did not have amniotic membrane placed. (article in press)
Growth Factors, Immune Modulators, Anti-Inflammatory Agents and more.
MODULATE CORRECT TISSUE RECONSTRUCTION
The placental Extracellular Matrix (ECM) modulates correct tissue reconstruction rather than scar tissue formation. This ECM includes growth factors, fibronectin, laminin, hyaluronic acid, proteoglycans, and other proteins.
REGULATES INFLAMMATION & FIBROSIS
Anti-inflammatory and anti-fibrotic proteins in placental ECMs reduce inflammation, fibrous tissue growth, and potential scar tissue formation as they downregulate TGF-B, suppress pro-inflammatory cytokines, and inhibit MMPs and fibroblast formation.
NON-IMMUNOGENIC
Placental tissues possess little risk of foreign body reaction in the patient, which can lead to fibrosis and graft failure. They perform a similar role during pregnancy, preventing a response between baby and mother.
ANTI-MICROBIAL
Placental tissue contains components that help to create a healthy environment by potentially reducing bacteria counts in the wound. Its antibacterial effects have been demonstrated against a wide range of bacteria.
FOUNDATION FOR REGENERATION
Placental ECMs contain Collagens I, III, IV, V, VI, VII, and fibrous proteins that provide a structural scaffold to support migration. Fibronectin, integrins, laminin, and hyaluronan also play a key role in proliferation, differentiation and adherence to the scaffold.
Both the "Amniotic Laryngeal Nerve Shield" and the "Amniotic Parathyroid Shield" is a patented product with multiple potential benefits. The size, shape, and application process for both the nerve and parathyroid gland are proprietary and protected from imitators. Dr's Norman has worked with engineers and technicians to develop an instruction manual that allows the Nerve Shield to be placed in about 30 seconds, and the Parathyroid Dot in about 10 seconds. Amnioduvet's sales team has been trained on the use of the Amniotic Laryngeal Nerve Shield by Dr Norman and his staff in their operating rooms and serve as instructors providing guidance to it's proper use during surgery.
Surgeons, use this database to locate a Amnioduvet sales team member in your town who will bring the Nerve Shield directly to your operating room and provide you the guidance and instructions to use it the first time.
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Patented Design, Methods, Techniques & Application