On April 28, the state administration of drug administration approved the listing of two of the country's first innovative medical devices. That has led to the increase in the number of domestic blockbuster products that the fda has approved since 2017. 

 

The two newly approved products are: 

 

Beijing yongxin medical equipment co., LTD. : the variable Angle dual probe single photon emission computer tomography equipment 

 

The product was launched on Feb. 4, 2016, on Feb. 22, 2016, and was approved for the approval of the special approval process for innovative medical devices, which took a little more than a year. 

 

This is domestic first variable Angle, fully digital double probe clinical general SPECT, by adding more pinhole collimator, without probe rotation can be realized with small organs such as heart, thyroid precision of image acquisition and efficiently. 

 

This product is composed of main engine, check bed, power distribution cabinet, collimator, collect processing station and collect main control station. The main engine includes gamma photon probe, collimator, frame, cantilever monitoring terminal and manual box module. Nuclear medical diagnosis for nervous system, cardiovascular, tumor. 

 

Pu yi (Shanghai) bio-technology co., LTD. : fully degradable sinus drug stent system 

 

The product was launched on June 6, 2016, on June 20, 2016, and was approved for a special approval process for new medical devices, which will take about 10 months. 

 

This is the first biodegradable sinus drug stent in our country. 

 

The product consists of a self-expansion and fully decomposed sinus stent, drug-coated, conveyer system and auxiliary tools. The stent was made of propyl-ethyl-ethyl ester copolymer, and the drug coating was made up of the drug, mermipine, propylley-ethyl and polyethylene glycol. The functional endoscopic sinus surgery (FESS) for chronic sinusitis is applied to prevent adhesion of FESS, keep the nasal passages open and reduce inflammation. 

 

The product USES its mechanical support to keep the middle nasal passages open, avoiding the middle turbinate and the lateral wall of the nasal cavity, which is beneficial to the opening of sinuses. Carry the directional release drug in lesion site, inhibit inflammation and hyperplasia of nasal polyps, solved the patients medication compliance and nasal passages in nasal spray hormone is not easy to reach deep problems, for nasal polyps and sinusitis in patients with refractory sinusitis patients provides a new way of treatment; The complete degradation of the product allows the patient to avoid the pain of withdrawal. 

 

In January and February, the state administration of drug administration announced two new blockbuster products approved for sale. 

 

Beijing bairen medical science and technology co., LTD. : pulmonary artery belt pipe product 

 

The first approval of the product has filled the gap in the field of high-end artificial biological heart valves for domestic medical devices. 

 

The product is composed of the near and far core pipes, which are the same as the internal diameter of the discharge ends (8-17mm). Close to the heart with a native client pipeline in bovine jugular vein group in the 3 leaf valve, valve on the far side pipe using bovine pericardial tissue heart, through the cell, remove immunogenicity and series of tissue calcification resistance modification, then through the bionic structure design and sewing process. The product by the artificial biological pulmonary valve and without stents creatures of great vessels, used for cardiac surgery implants, surgical reconstruction of right ventricular outflow tract or replace the previously implanted loss pipeline, treatment of right ventricular outflow tract malformation or pathological changes of the patients. 

 

Haijya (Beijing) medical instrument co., LTD. : cryogenic cryosurgery system and disposable sterile cryogenic injection 

 

The product listed is conducive to further break the tumor freezing and melting the situation of market is monopolized by foreign manufacturers, substantial cost reduce tumor cryoablation treatment at low temperature, at the same time, promote the development of tumor minimally invasive treatment of relevant industries. 

 

The system is mainly composed of cryoablation needles, transmission lines, low temperature vessels, high temperature container, fluid electrical control system, computer control system and data acquisition system, used in clinical except cavity tumor freezing treatment of solid tumors. 

 

The system adopts the ultra-low temperature freezing and thawing of multimodality treatment mode, a breakthrough in the liquid nitrogen refrigeration probe refining technology, through cryogenic hockey surrounded by destruction of tumors, avoid the tumor cells are out to normal tissue ablation needle hidden trouble, reduce the risk of bleeding. In addition, the system performance indexes such as refrigeration temperature has certain advantages, through the use of commonly used liquid nitrogen and anhydrous ethanol as main material, reduces the use cost.