Hydrocephalus is a common and serious condition in the field of neurosurgery
Projections based on number of persons in each age group and prevalence rate
China's hydrocephalus patients are about 1.7-2.11 million👇
In response to this disease, recently, there is good news from the new area enterprise Pulimont:Its self-developed "disposable hydrocephalus shunt and components" passed the examination of the State Drug Administration of the proposed product registration, and was successfully approved the registration certificate of Class III medical devices.
As the first product in China, its approval is expected to bring new hope to millions of hydrocephalus patients in China. It is worth mentioning that this is also the first time that PrimonThe second Class III medical device registration certificate taken in the last two months or so.
01
Before introducing the product, let's do a little science: hydrocephalus accumulation of "water", refers to the cerebrospinal fluid in the cranial cavity in the accumulation of too much.
Our brain is originally immersed in cerebrospinal fluid (CSF), which is like a "moat" that protects the brain under normal conditions. Under normal circumstances, cerebrospinal fluid is like a "moat" that protects the brain. However, when there is an obstacle in its secretion, circulation or absorption, the water level of this "river" will rise abnormally and pressurize the brain, triggering increased intracranial pressure, neurological dysfunction, eye disorders, and so on.
When the "water table" gets high, it needs to be shunted. Currently, cerebrospinal fluid shunting is the key treatment for hydrocephalus - a shunt system is implanted in the body to drain excess cerebrospinal fluid from the ventricles of the brain to other parts of the body to be absorbed.As a key consumable, the shunt system is directly related to surgical resultsHowever, the market has long been monopolized by international giants.
"At present, the domestic use of similar products are imported, a set of better cumulus shunt system will be tens of thousands of dollars, not only the patient and the health insurance burden, the supply chain is also at risk." Pulimont relevant staff introduction. Because of this, they are determined to attack the problem, and finally realized the domestic breakthrough.
It is understood that the approved "single-use hydrocephalus shunt and components" can drain patients' excess cerebrospinal fluid from the ventricle to the peritoneal cavity for absorption. At the same time, it is alsointernal (a country)First to combine "adjustable pressure" and "anti-siphon" functionsTriage productsThe
You may wonder: what is the function of "adjustable pressure" and "anti-siphonage"? It is important to realize that most previous cerebrospinal fluid shunt systems have a fixed differential pressure, which makes it easy to under- or over-drain, leading to multiple complications and the need for re-operation and replacement of the shunt after a certain period of time.
To address this pain point, the "adjustable pressure" function of Primo's new product allows doctors to adjust the pressure setting outside the body at any time according to the patient's postoperative performance and clinical symptoms.Significantly reduces the risk of secondary surgery.;
At the same time, the product is equipped with an "anti-siphon" device, which can reduce the occurrence of excessive drainage, reduce the risk of complications such as subdural hematoma, and reduce the burden on the patient.
02
In a market long dominated by overseas giants, Primo's domestic first is a technological leap for its team in the field of high-end consumables for neurosurgery.
More importantly.The approval of domestic products also means that domestic patients will enjoy international standard medical solutions at a lower cost.
A first-of-its-kind product is approved, benefiting millions of patients.
As a company focusing on the research and development and industrialization of high-end medical consumables, Plimont has been running forward in the fields of innovative material research and development and high-end medical device design and manufacturing. Previously, the team has independently developed such innovative medical devices as absorbable surgical sutures, absorbable hemostatic clips, absorbable cranial locks and other products, which have been applied in many tertiary hospitals across the country. in July, the company also completed the C round of financing of nearly 300 million yuan.
The independent control of high-end medical equipment is also a solid foundation for guarding life and health. Primavera staff said that the team will continue to research and develop according to the clinical needs, and continuously improve the production capacity. In the future, we are looking forward to more innovations.
