At the end of 2021, Professor Lu Xinwu of the Department of Vascular Surgery of the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (hereinafter referred to as "Shanghai Nine Hospitals"), together with a team of experts such as Professor Ye Chuangchuang, Professor Shi Huihua and Professor Peng Zhiyou, successfully completed three clinical trials of LuVoCaptor thromboter independently developed by Shanghai Weiyu Medical Technology Co., Ltd., a subsidiary of Leao Medical Holdings.
In three clinical trials, Leo Medical's LuVoCaptor thrombotic catheters performed well, with a venous thrombosis clearance rate of more than 90%, and patients with little trauma and rapid recovery. At the same time, the thrombotic catheter can not only effectively remove acute thrombosis, but also remove subacute or even old thrombosis, reducing the occurrence of PTS (postthrombotic syndrome).
Case 1
※ Basic Information:
The patient, female, 65 years old, was admitted to the hospital for "6 days of swollen pain in the lower left limb". The skin temperature of the left lower extremity is slightly low, the swelling is from the back of the foot to the middle of the left thigh, showing non-depressed edema, Honmans sign (+), deep vein thrombosis of the left lower extremity, and percutaneous mechanical thrombotomy (hereinafter referred to as PMT) is planned.
※ Surgical procedure:
The patient is in the supine position, punctures the common femoral vein on the right side of the knee, contrast localization of the inferior vena cava, renal vein position, placement of a recoverable vena cava filter. Puncture of the left popliteal vein, placed in the guide sheath, sequentially inserted LuVoCaptor suppository catheter from the popliteal vein to the iliac vein, and then to the inferior vena cava, angiographic examination, showing that the blood clot in the femoral vein is basically cleared, the common iliac vein is not cleared, confirming the existence of iliac vein compression syndrome, accompanied by balloon dilation of the femoral vein, iliac vein, common iliac vein, and then implanted stent.
※ LuVoCaptor luminal contrast control before and after embolic removal:
Preoperative luminal angiography
Luminal angiography after thrombotomy
※ Thrombosis removal by thrombotic surgery:
※ Postoperative follow-up:
After the operation, the patient had no complaints of special discomfort, good spirits, obvious regression of surgical extremity swelling, good blood transport at the ends of the surgical limbs, arterial pulsation, bilateral gastrocnemius muscle weakness, and normal sensation and movement of both lower limbs. The case was followed up three times, with ultrasonography and CTA examination, and the results were good.
Case 2
The patient, a 61-year-old female, was admitted to the hospital for "4 days of swollen pain in the lower left limb". The skin temperature of the left lower extremity is slightly lower, the swelling is from the back of the foot to the middle of the left thigh, it is non-concave edema, Honmans sign (+), deep vein thrombosis of the left lower extremity, and PMT is proposed.
The patient is in the supine position, puncture of the common femoral vein on the right side of the knee, contrast localization of the inferior vena cava, renal vein position, placement of a recoverable vena cava filter, puncture of the left popliteal vein, placed in the guide sheath, using LuVoCaptor to take the thrombotic catheter to act as a target lesion, immediately after the thrombotic retrieval, immediate contrast examination shows thrombosis clearance > 90%. The filament catheter is coordinated to return to the true cavity through the narrow occlusive segment of the left iliac vein, followed by balloon dilation, and then implanted with wallstent stents. Re-imaging showed continuous visualization of the left superficial femoral vein, femoral vein, iliac vein, vena cava, and filter, and no obvious filling defects were seen, the blood flow speed in the tube wall form was fast, and the contrast agent had no extravasation.
The patient is mentally visible, the surgical limb skin is not pale, no cyanosis, no swelling, a small number of ecchymosis near the puncture point, no hematoma and no exudation, soft gastrocnemius muscles, dorsal artery pulsation can be reached, and both lower limbs feel motor barrier-free. The case was followed up three times, with ultrasonography and CTA examination, and the results were good.
Case three
The patient, a 77-year-old female, was admitted to the hospital for "a week of swelling and pain in the lower left limb". Swelling of the left lower extremity, difficulty walking, accompanied by pain, marked swelling after walking, slightly lower skin temperature in the left lower extremity, swelling from the back of the foot to the middle of the left thigh, depression edema, Honmana sign (+), deep vein thrombosis of the left lower extremity, pseudo-PMT.
The patient is in the supine position, puncture of the common femoral vein on the right side of the knee, contrast localization of the inferior vena cava, renal vein position, puncture of the popliteal vein, placement of a recoverable vena cava filter, puncture of the left popliteal vein, placed in a guide sheath, use LuVoCaptor to take a suppository catheter to target the lesion, after the embolectomy, contrast examination shows > thrombosis clearance 90%, 50% of the target vascular residual stenosis after thrombotic retrieval. The filament catheter is coordinated to return to the true cavity through the narrow occlusive segment of the left iliac vein, followed by balloon dilation, and then implanted with wallstent stents. Re-imaging showed continuous visualization of the left superficial femoral vein, femoral vein, iliac vein, vena cava, and filter, and no obvious filling defects were seen, the blood flow speed in the tube wall form was fast, and the contrast agent had no extravasation. The target lesion is narrowed by 10% after stent implantation.
The patient is clear, the left lower extremity is mildly swollen, the gastrocnemius muscle is soft, the dorsal artery pulsation of the foot can be reached, the sensorimotor movement of both lower limbs is barrier-free, and the puncture point of the lower extremity is grade A healing. The case was followed up three times, with ultrasonography and CTA examination, and the results were good.
Venous thrombosis develops gradually, and subacute thrombosis becomes a clinical problem
Peripheral venous diseases that are "invisibly all year round" are gradually gaining attention in the mainland.
Deep vein thrombosis (DVT) is a common peripheral vein disease in the clinic. According to Frost & Sullivan, there were 1.5 million people with deep vein thrombosis on the mainland in 2019, which is expected to increase to 3.3 million by 2030. Clinically, most patients with deep vein thrombosis have no obvious symptoms, so the proportion of early missed diagnosis and misdiagnosis is high, and only 20% of deep vein thrombosis is clinically diagnosed.
Deep vein thrombosis is a "dangerous" disease that may cause complications including pulmonary embolism (PE), PTS, and in severe cases, shock or even death. According to the time of onset, deep vein thrombosis can be divided into acute phase (within 14 days of onset), subacute phase (15 days to 30 days onset), chronic phase (also known as old thrombosis, 30 days after onset).
In recent years, techniques for deep vein thrombosis have developed rapidly, but most treatments are only for acute thrombosis. However, the development of thrombosis is gradual, and there may be acute, subacute, or even obsolete thrombosis in the veins of a diseased period. Subacute thrombuses adhere to the walls of blood vessels and are difficult to remove, and may cause damage to the walls if the thrombus is forcibly removed. Unrefined blood clots can eventually develop into fibrotic substances, forming PTS, which can seriously affect the patient's quality of life.
The world's first intravenous embolic embolism technology, which can take subacute thrombosis
Due to the difficulty of removal, subacute venous thrombosis has always been a clinically difficult problem. At present, common intravenous embolic catheters on the market are AnioJet of Boston Scientific and Aspire S of Bidy Medical, both of which are mainly used to remove acute venous thrombosis.
In the recent three clinical trials, the LuVoCaptor thrombotic catheter has shown excellent thrombosis clearance ability, making acute thrombosis "unavoidable", and can also clear subacute thrombosis, achieving good clinical results.
LuVoCaptor thrombotic catheter does not rely on special equipment and thrombolytic agents, in order to achieve a good thrombolytic effect, for clinical difficulties designed instantaneous suction, can achieve a strong suction force in a short period of time, to ensure the rapid suction out of the clumpy, viscous shaped thrombus. The procedure requires only the hospital's existing negative pressure pump, saving up to one million in equipment costs.
Therefore, this device is easier to sink to the grassroots level, reduce the overall treatment cost of patients, and meet the needs of timely and nearby treatment of deep vein thrombosis.
Since the opening of the first clinical enrollment in Shanghai Ninth Hospital in June 2021, Leo Medical's thrombotic catheter has achieved good clinical results, with an average thrombosis clearance rate of more than 90%, and is expected to be listed in 2024.
Ge Quanbo, co-founder of Leo Medical, vice president of R&D and general manager of Weiyu Medical, introduced: "As a world-first product, the future listing of peripheral vascular thrombotic catheters will better meet the needs of grass-roots doctors due to its high thrombotic clearance, short doctor learning curve and high treatment efficiency. ”
This product is the original product of Leo Medical, which is a case of iterative improvement of clinical needs through continuous trial and error, so that innovative concepts can evolve into clinical products.
Anchor the peripheral intervention in the market and consolidate the product pipeline layout
Since its establishment in 2011, Leo Medical has gone through 10 years of wind and rain, sown the seeds of technology and products, and gradually built six core technology platforms - metal stent platform, polymer catheter platform, active device platform, degradable material platform, visual technology platform and drug carrier device platform, with more than 50 technology patents.
Based on the combative execution team and innovative technology platform, aiming at clinical needs, Leo Medical has a wide layout in the three major areas of peripheral intervention, digestive intervention and respiratory intervention.
In the field of peripheral intervention, the company also laid out peripheral arterial vascular products and peripheral venous vascular products, and innovatively developed products such as peripheral intravenous embolic catheters and intravenous stents. The company's peripheral vascular balloon dilation catheter has been approved in May 2019, and the peripheral arterial stent has completed all clinical enrollment in March 2021, and is expected to be certified and listed in 2023, becoming the first peripheral vascular artery series long stent (the longest specification is 200mm) in China.
According to the Guidelines for the Diagnosis and Treatment of Deep Vein Thrombosis (Third Edition) published in 2017, treatments for the disease include vascular thrombosis, balloon dilation, and stent implantation. LeaoMedicine's developed thrombotic catheters, PTA balloon catheters, and peripheral venous stents provide a holistic solution for deep vein thrombotherapy.