Kossel Medtech Co., Ltd.

25/04/2021

Benefits & Safety of Coronary Angioplasty

A coronary angioplasty is a procedure used to widen blocked or narrowed coronary arteries (the main blood vessels supplying the heart).

What are the benefits of a coronary angioplasty?

In most cases, the blood flow through the coronary arteries improves after an angioplasty. Many people find their symptoms get significantly better and they’re able to do more than they could before the procedure.

If you’ve had a heart attack, an angioplasty can increase your chances of surviving more than clot-busting medication (thrombolysis). The procedure can also reduce your chances of having another heart attack in the future.

How safe is a coronary angioplasty?

A coronary angioplasty is 1 of the most common types of treatment for the heart.

Coronary angioplasties are most commonly performed in people aged 65 or older, as they’re more likely to have heart disease.

As the procedure doesn’t involve making major incisions in the body, it’s usually carried out safely in most people. Doctors refer to this as a minimally invasive form of treatment.

The risk of serious complications from a coronary angioplasty is generally small, but this depends on factors such as:
→your age
→your general health
→whether you’ve had a heart attack
Serious problems that can occur as a result of the procedure include:
1)excessive bleeding
2)a heart attack
3)a stroke

(source:https://www.kossel-medical.com/2021/02/05/benefits-safety-of-coronary-angioplasty/)

05/02/2021

What is catheter (PTCA) treatment?

Catheter treatment (percutaneous transluminal coronary angioplasty, or PTCA dilatation balloon catheter, treatment) is one of the methods of treatment for diseases such as angina pectoris and myocardial infarctions that are caused by the heart’s blood vessels (coronary arteries) becoming clogged or narrowed by cholesterol.
Previously it was common to treat such diseases with medication or, if symptoms were heavy, with coronary artery bypass grafting, major surgery with thoracotomy. In recent years, catheter treatment (PTCA treatment), where narrow tubes called catheters are inserted from the wrist or from the base of the foot to widen narrowed blood vessels, has been making notable progress.
Since the treatment doesn’t require thoracotomy, there is little pain for patients (minimally invasive) and the economic burden is lighter such as due to the shortened length of hospital stay which allows early social rehabilitation, and it has now become the main method of treatment for coronary artery diseases.

1. Passing through of PTCA guide wire

2. Insertion of PTCA balloon catheter

3. Inflation of PTCA balloon catheter

4. Withdrawal of PTCA balloon catheter

(source:https://www.kossel-medical.com/2021/01/30/what-is-catheter-ptca-treatment/)

31/12/2020

Kossel’s Balloon Catheter Applied in Minimally Invasive Surgery

What types of balloon catheter do Kossel offer?

Kossel provides a variety of balloon catheters, including PTCA, NC PTCA, PTA, CTO balloon dilatation catheters which meet major clinical applications.
What is Minimally Invasive Surgery?
Minimally invasive surgery refers to any surgical procedure that is performed through tiny incisions instead of a large opening. Because your surgeon will make smaller incisions, you will likely have a quicker recovery time and less pain than traditional open surgery but with the same benefits as traditional surgery.
The benefits of minimally invasive surgery include:
• Smaller incisions
• Less pain
• Minimal to no scars
• Less blood loss
• Lower rate of complications
• Shorter hospital stay

(source:https://www.kossel-medical.com/2020/12/25/kossels-balloon-catheter-applied-in-minimally-invasive-surgery/)

26/12/2020

Instruction for Percutaneous Coronary Intervention (PCI)

What is PCI?
Percutaneous Coronary Intervention (PCI, formerly known as angioplasty with stent) is a non-surgical procedure that used primarily to open a blocked coronary artery and restore arterial blood flow to heart tissue, without requiring open-heart surgery. In patients with a restricted or blocked coronary artery, PCI may be the best option to re-establish blood flow as well as prevent angina (chest pain), myocardial infarctions (heart attacks) and death. Today, PCI usually includes the insertion of stents, such as bare-metal stents, drug-eluting stents, and fully resorbable vascular scaffolds (or naturally dissolving stents). The use of stents has been shown to be important during the first three months after PCI; after that, the artery can remain open on its own.

pta balloon catheter

What is done?
a.A catheter is inserted into the blood vessels either in the groin or in the arm.
b.Using a special type of X-ray called fluoroscopy, the catheter is threaded through the blood vessels into the heart where the coronary artery is narrowed.
c.When the tip is in place, a pta balloon catheter tip covered with a stent is inflated.
d.The balloon tip compresses the plaque and expands the stent.
e.Once the plaque is compressed and the stent is in place, the balloon is deflated and withdrawn.
f.The stent stays in the artery, holding it open.

Kossel’s Solutions for PCI
Kossel offers a wide range of array for cost-effective PTCA balloon dilatation catheter. More than 30 countries’ customers are using Kossel’s products for PCI procedures. Quality you can trust. For more information on our products and services, please contact marketing@kosselmed.com. Thank you.

(source:https://www.kossel-medical.com/2020/12/12/instruction-for-percutaneous-coronary-intervention-pci/)

14/11/2020

Selethru® Balloon Dilatation Catheter: Easy to Know Me, Hard to Forget Me

Balloon Catheter

I always think that balloon catheter should be the first lesson for medical personnel to understand the equipment or device. Not to mention its volume in today’s market, it is worth observing and learning; the design concept of the product alone and the technology involved are enough to support a world. Because there are too many branches of balloon, let’s take Selethru® Balloon Dilatation Catheter of Kossel Medtech as an example, and we can draw inferences from others.

Balloon catheter with good bending performance and smooth tip design has been used in the dilatation therapy of a variety of diseases. There are mainly two kinds of high-quality balloon materials on the market, one is Nylon, the other is PEBAX. They can smoothly enter the position of semi occlusion or complete occlusion. The design of developing ring can accurately determine the position of the balloon when used. The structure of the balloon dilatation catheter will be introduced in detail below.

The size and performance parameters (such as diameter, length, and hardness) of the tip of the balloon catheter can directly affect its ability to pass through the lesion. Tip laser forming technique makes the balloon with a small entrance, which can enhance the performance of crossing the stenosis; Soft tapered tip is designed to enhance the traceability of the catheter with the guidewire. In general, a balloon dilation catheter with a short hard tip is suitable for the treatment of severe stenosis lesions, while the long soft tip catheter is more suitable for the treatment of tortuous lesions.

The material of the balloon has a great influence on the compliance of the balloon catheter. The balloon compliance of PET is lower than that of POC. The semi-compliant balloon is usually made of PEBAX, while the non-compliant balloon is usually made of Nylon. The 3-wings balloon fluting ensures that the balloon has a minimum profile to cross the stenosis easier. The material of the balloon also affects the retraction performance of the balloon. Retraction performance refers to the recovery ability of balloon diameter after balloon expansion and suction. It is one of the indexes to evaluate the crossability of the balloon. Nowadays, the super-lubricity hydrophilic coating is widely used on the surface of the balloon for superior delivery performance. Moreover, the advanced laser bonding technology ensures the balloon and the catheter smooth transition connection, which makes better crossability.

The domestic well-known shafts for balloon catheters are divided into polymer materials and metal materials. The shaft with polymer material can reduce the friction while advancing, and the shaft with metal material can have a better delivery performance. The integrated shaft system of Selethru® Balloon Dilatation Catheter is made of Hypo tube. It is a polymer-coated stainless-steel tube. The steel construction is designed to optimize proximal push ability with a smooth transition to a distal shaft. Meanwhile, a hydrophilic coating is applied to the outside surface of the distal shaft to reduce friction force with the vascular wall.

To sum up, the main composition of the balloon dilatation catheter includes a tip, balloon, and integrated shaft system. Besides, as the link between the shaft system and the balloon, the connecting section has a great impact on the delivery performance and bending resistance of the balloon. The central steel wire is usually placed in it to enhance the supporting force, to improve the delivery performance and bending resistance.

(source:https://www.kossel-medical.com/selethru-balloon-dilatation-catheter/)

07/11/2020

Global Certificated Product——Selethru® PTCA Balloon Dilatation Catheter
Selethru® PTCA Balloon Dilatation Catheter is a rapid exchange balloon system, which can be used to dilate coronary artery stenosis and improve myocardial blood supply.
Product features:
Selethru® is a high-end balloon catheter product elaborately created by Kossel Medtech. It adopts the latest material and structural design in the industry. The product has the smallest profile in the same specification in the industry at present. Through the outer diameter and the softest material, it has achieved excellent ability to pass through narrow and tortuous lesions, which is superior to CTO lesions.
The performance size design of the product can meet the specification of 1.0-2.0 mm. Two balloon catheters can be included in the 5F catheter, which is convenient for doctors to carry out kissing operation, so that the main branch and the side branch of bifurcation disease can benefit from the interventional treatment at the same time.
At the same time, the balloon performance of the product such as tension expansion and compressive strength has reached the leading level in the industry. This registered model covers 11 diameters (1.0 mm-4.0 mm) and 5 lengths (10 mm, 15 mm, 20 mm, 25 mm, 30 mm) with a total of 49 specifications.
Selethru® has obtained the CE certification of European Union, FDA of the United States Food and Drug Administration, KFDA of Korea and CFDA of National Food Quality Supervision and Inspection Center, which marks the global certification of Kossel Medtech balloon catheter, which has reached the international advanced level, so as to further improve the market competitiveness of Kossel Medtech balloon dilatation catheter products increase the market share of coronary artery products at home and overseas.

(source:https://www.kossel-medical.com/global-certificated-product-selethru-ptca-balloon-dilatation-catheter/)

23/10/2020

What to know about angioplasty
Angioplasty is a medical procedure that opens up a blocked or narrowed artery around the heart. It is a standard treatment for narrowed or blocked arteries in this area of the body. Doctors also refer to angioplasty as percutaneous coronary intervention, or PCI.
During angioplasty, a surgeon inserts a tube into an artery in the groin or wrist. They then thread the tube towards the affected artery around the heart. Finally, they insert a balloon or stent (metal tube) to open the artery. Doctors perform more than 1.2 million angioplasties a year in the United States, according to the American College of Cardiology.
Here, we give an overview of angioplasty or PCI, including its uses, types, risks, procedure, and recovery.

What is angioplasty?

In the term angioplasty, “angio” means blood vessel, and “plasty” is opening up. In PCI, the “P” stands for percutaneous or “through the skin” while coronary refers to the location of blood vessels around the heart.
Angioplasty is a conventional treatment for coronary heart disease (CHD) and heart attacks (acute coronary syndrome). In these conditions, there is a buildup of plaque, or atherosclerosis, on the walls of the arteries.
As plaque accumulates, the arteries narrow and can become blocked. In a heart attack, the plaque may rupture, spilling cholesterol into an artery, potentially leading to a clot that stops blood flow.
During a standard angioplasty, the doctor makes an incision in the groin or wrist and inserts a tube, or catheter, into an artery. Next, they thread the catheter upwards and into the affected blood vessel around the heart. Usually, the catheter contains an inflatable balloon that displaces the plaque or clot, effectively opening up the artery. Doctors use live X-rays and a contrast dye to guide the catheter and assess the arteries they need to treat.
Compared with heart surgery, angioplasty is a minimally invasive as it does not involve opening up the chest.
Doctors may recommend angioplasty to:
·treat an abnormal stress test
·increase blood flow to the heart
·reduce chest pain, or angina
·improve blood supply to the heart muscle during or after a heart attack
·support more activity for people with chest pain

Types
There are two main types of angioplasty:
Balloon angioplasty, which involves using the pressure of an inflating balloon to clear plaque that is blocking an artery. This is rarely done alone except in cases when doctors are unable to place a stent in the required position.
Stent placement in the artery, which involves a tube, or stent, made out of wire mesh. Stents help to prevent an artery narrowing again after angioplasty.

Stents may be made of bare metal or have a coating of medication. When they include medication, they are called drug eluting stents (DES) and are less likely to plug up again.
DES are now used almost exclusively with very little use of bare metal stents.
Research from 2018 estimates that doctors in the U.S. implant over 1.8 million stents each year.

How to prepare
Angioplasty is a minimally invasive procedure, but it is still surgery, and people must follow their doctor’s instructions carefully beforehand.
People need to inform their doctor about any medications and supplements they are taking. In some cases, they may need to stop taking these drugs, especially blood thinners, before the procedure.
Also, an individual may need to avoid food or drinks for several hours before the angioplasty procedure as doctors will need to sedate them.
Kidney tests may be needed beforehand, too, as the contrast dye that the surgeons use can affect kidney function.

Procedure
Before beginning angioplasty, a healthcare professional will clean and numb the area where the catheter enters the body, usually the groin but sometimes the wrist.
Next, a doctor inserts the catheter into the artery and directs it towards the coronary artery, watching its progress on an X-ray feed.
Once the catheter is in position, the doctor injects a contrast dye through the artery, which helps identify blockages around the heart. Once they locate the blockages, the doctor inserts a second catheter and a guidewire, usually with a balloon at the tip.
When the second catheter is in position, the doctor inflates the balloon, which pushes the plaque buildup away and opens up the artery. The surgeon may insert a stent to keep the artery propped open.
According to the American Heart Association, angioplasty can take anywhere from 30 minutes to a few hours. The person may need to stay in hospital overnight.

Risks
On the whole, angioplasty is a safe procedure without complications.
One estimate says the rate of complications is 5 in every 100 people, with fewer in large institutes that specialize in angioplasty.
Although complications from angioplasty are rare, they can include:
·prolonged bleeding from the catheter insertion site in the groin or wrist
·damage to blood vessels, kidneys, or arteries
·an allergic reaction to the dye
·chest pain
·arrhythmia, or abnormal heart rhythm
·a blockage that requires an emergency bypass
·blood clot
·Stroke
·heart attack
·a tear or damage to artery or major blood vessel
·death
Older individuals have a higher risk of complications from angioplasty, as do those with the following conditions:
·heart disease
·several blocked arteries
·chronic kidney disease
There is also a chance of the artery becoming blocked with plaque again through a process called restenosis, plaque shift, or stent thrombosis, which is a clot in the stent.

Recovery
When angioplasty is complete, the cardiologist removes the catheters and bandages. Soreness, bruising, and possibly bleeding are common around the area where catheters entered the body.
Typically, a person will recover in the hospital for a few hours or overnight before going home. They must not drive as they may still have sedative medications in their system. They will also have restrictions on lifting for about a week afterward.
People can often return to work within a week, but their doctor will advise on how active they can be and when.
The follow-up visit after angioplasty is a key aspect of the treatment. The doctor will review the individual’s recovery, adjust medications as they need, and develop an ongoing treatment plan for their cardiovascular health.

Summary
Angioplasty is a standard, minimally invasive procedure that doctors use to unblock clogged arteries and improve blood flow in the heart. Doctors frequently recommend angioplasty to treat acute heart problems. It is generally a safe procedure, although arteries can become blocked again, and there is a small risk of significant complications in some cases.

(source:https://www.kossel-medical.com/what-to-know-about-angioplasty/)_

12/09/2020

Safety Questions on Paclitaxel Coated Balloons
The safety of paclitaxel eluting stents and drug-coated balloon catheter was first brought into question by a meta-analysis published in Journal of the American Heart Association in December 2018. That analysis showed a higher mortality rate at two years post-procedure and prompted the U.S. Food and Drug Administration (FDA) to release its first warning letter on the subject. At that time, the agency asserted that the benefits of paclitaxel-coated devices outweighed the possible risks when used as indicated, but more data was needed. In August 2019, the FDA released an updated MedWatch Alert after reviewing long-term follow-up clinical data. The agency said five-year results from three randomized trials showed an increased mortality rate in patients treated with these devices compared to those treated with uncoated devices. While these data provide reason for caution, the FDA noted that the devices still provide documented short-term benefits.
A whole day of discussion at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 conference FDA town hall meeting was devoted to presentations and debate about the safety of paclitaxel. Discussion centered on the clinical data to date, what is being done to gather more clinical information to prove or disprove any safety signals, and what hypothesis could be agreed on for how this signal appeared in the first place. No agreement could be found by the panel because there is no single issue identified as to what might be causing increased mortality.
Several experts on the panel discussion raised questions if this was an anomaly in the data caused by chance. Some suggested the data may be skewed by up to 25 percent of trial participants being lost to long-term follow-up and only the sickest patients remaining in the study cohorts.
Cardiovascular Research Foundation (CRF) CEO Juan F. Granada, M.D., who was heavily involved in DCB development, said he questions if there is an actual safety concern because there is no smoking gun connecting deaths across several trials to any particular cause. He said paclitaxel from the device does not appear to be causing any specific issues elsewhere in the body.
Others said the cause could be related to factors such as the combination of other drugs patients are taking and possible reactions with the paclitaxel. Others said it appears to be just a random coincidence, since there are no specific factors linking any of the deaths.
However, efforts are underway to gather additional data from Medicare to see if there are any patterns in care or drugs used in the patients who died. Also, questions have been added to new and ongoing trials for other paclitaxel-eluting devices that should offer more information from at least 16,000 patients in the next couple years.
One of the late-breaking trial presentations at TCT shed additional light on the issue. It was an independent analysis of Lutonix 035 DCB patient-level data showed no statistically significant mortality increase. This was one of the first major reviews of trial data for patients who were treated with a paclitaxel coated device used in peripheral vessels since the safety issue was first raised.
“As a peripheral operator that has greatly enjoyed the revolution in technology and the reduction in stenosis with the use of drug-eluting balloons in the lower extremities, a lot of us were ver saddened to here that drug-eluting balloons might be related to some type of systemic mortality risk, But mechanistically, it has never made sense to me that a lower-dose elution of paclitaxel from a balloon could somehow systemically cause some sort of mortality signal, explained Chandan Devireddy, M.D., cath lab director at Emory University Hospital Midtown, associate professor of medicine of interventional cardiology at Emory University, and chairperson for the Society of Cardiovascular Angiography and Interventions (SCAI) Communications Committee.
“But, looking at the LEVANT data for the Lutonix balloon, there does not appear to be that mortality signal, and that data goes out five years, hopefully this will bring that whole armamentarium of drug-eluting balloons back onboard with a new degree of comfort. This study shows there is data supporting the safe use of these devices,” Devireddy said.

(source:https://www.kossel-medical.com/safety-questions-on-paclitaxel-coated-balloons/)

The safety of paclitaxel eluting stents and drug-coated balloon catheter was first brought into question by a meta-analysis published in Journal of the American Heart Association in December 2018.

05/09/2020

Clinical Application of Drug-Coated Balloon in The Treatment of Coronary Artery Disease
Drug-coated balloon catheter(DCB) is a new treatment strategy for coronary artery disease, which is mostly used for the treatment of in-stent restenosis (ISR) after bare-metal stents and drug-eluting stents. Recent studies have shown that DCB has good efficacy and safety in patients with small vessel disease and high risk of bleeding. Recently, the international DCB consensus group released the latest guidelines on the use of DCB in coronary artery disease, focusing on the new indications and emerging technologies of DCB.
Coronary stents can reduce restenosis and prevent acute occlusion after balloon angioplasty. The application of dual antiplatelet therapy (DAPT) provides more favorable acute outcomes and lower restenosis rate than angioplasty alone. Drug-eluting stents (DES) can reduce ISR by continuously releasing drugs that inhibit intimal hyperplasia. However, even the second generation des has the problems of late-onset atherosclerosis and thrombosis events (such as stent thrombosis). The application of DCB can reduce this risk.

After angioplasty, negative vascular remodeling and neointimal hyperplasia can lead to restenosis. These processes are often slow and can be prevented by the sustained release of drugs that inhibit endometrial hyperplasia. Although different coatings were tested on the balloon catheter, local administration of paclitaxel eventually showed a significant reduction in the incidence of restenosis, an important aspect of which was positive remodeling.

Recently, sirolimus and its derivatives have been used in the study of DCB. Compared with paclitaxel, the transfer rate of sirolimus and its derivatives is poor and needs to be retained in tissues for a long time. At present, several local balloon-based administration methods of sirolimus and its derivatives have been proposed. In the preclinical model, the biological effect of using zotamox instead of paclitaxel coating was confirmed. The saber trial reports the first clinical experience of sirolimus delivered via a porous balloon in the treatment of coronary artery ISR. In the desired trial, paclitaxel-coated and sirolimus coated balloon groups had similar late lumen loss within 6 months and no difference in clinical events within 12 months.
At present, paclitaxel is still the first choice for DCB, and the conventional dose is 2 ~ 3.5μg /mm2. Different coating formulation and coating technology can bring different pharmacokinetic characteristics, which is one of the key factors for successful drug transfer. Therefore, the interaction among drug dosage, preparation, release kinetics and lesion seem to be the key to the vascular response after DCB treatment.

For uncomplicated lesions, it is recommended to use hemispheric saccule or non-compliant balloon with the same diameter as the artery. In the case of expected vessel filling or potential insufficient size and difficult balloon delivery, we can start with a smaller balloon and reassess the vessel size after the use of vasodilators. If the standard semi-compliant balloon fails to expand, a high-pressure noncompliant balloon or cutting balloon is recommended.

If calcification is present in the vessel wall, the use of these special balloons may produce more predictable and uniform pre-expansion results than standard balloons. For ISR patients, positive pre-expansion with a high-pressure balloon may be recommended to solve the serious problem of insufficient stent expansion. Besides, adjuvant treatment of lesion pretreatment, such as rotary milling, laser track rotary cutting, lithotripsy or prolonging dilation time, can promote the smooth progress of balloon angioplasty and subsequent drug treatment.

(source:Once the lesion has been pretreated, the best results of balloon angioplasty should be confirmed before the delivery of DCB, including the following factors: (1) a balloon that can be completely expanded and its size is consistent with the diameter of the artery; (2) residual stenosis≤30%; (3) TIMI blood flow grade 3; (4) no blood flow restriction, i.e. angiography must exclude vascular lumen, wall and any anatomy Delayed contrast agent clearance in the plane.

FFR is recommended to define functional outcomes in patients with acute lumen enlargement after pre-dilation, residual stenosis, and angiographic limitations. After two years of follow-up, FFR>0.90 showed that the improvement rate of angioplasty was lower than that of the previous two years. However, recent studies have shown that the optimal cut-off value of FFR after balloon angioplasty is set at 0.85 or even 0.75 to predict future outcomes. Despite the lack of valid data on the ideal FFR threshold after conventional balloon angioplasty, an FFR of 0.80 may be a good compromise for guiding angioplasty. This problem needs further study.

The transportability of the first generation DCB is lower than that of the standard balloon with larger cross-section, and the transportability of the contemporary DCB is improved. The recently used pre-dilated balloon can be used as a guide, but distal lesions, extreme tortuosity or excessive calcification may lead to DCB delivery failure. The catheter with good support, extensible guide, auxiliary wire and deep finger guide tube can be used as the choice of balloon transportation.

Before DAPT, balloon angioplasty for coronary artery disease was not widely used due to short-term and long-term adverse outcomes. Recently published randomized controlled study data show that DCB technology has the advantages of optimal lesion pretreatment, functional detection, inhibition of intimal hyperplasia, short-term DAPT, and has become an effective choice for the treatment of coronary artery disease in most clinical situations.

(source:https://www.kossel-medical.com/drug-coated-balloon/)

Drug-coated balloon catheter(DCB) is a new treatment strategy for coronary artery disease, which is mostly used for the treatment of in-stent restenosis (ISR) after bare-metal stents and drug-eluting stents.

15/08/2020

How to Optimize the Use of Drug Coated Balloon in Peripheral Arterial Disease?
At present, whether it is the possibility of drug-coated balloon (DCB) as a substitute for stent or its use method is still controversial. There is still room for improvement in the use of DCB. If the drug coating of DCB only acts on the target lesions, the amount of drug lost into the circulation of the body can be reduced, or the side effects of human body can be reduced.

Application of DCB
In the treatment of peripheral artery disease, DCB is allowed to be used for short and local lesions, but it cannot replace the stent implantation for long-term and calcified lesions.
Throughout the development of endovascular surgery, from balloon dilation/percutaneous transluminal angioplasty (PTA) to stent implantation, and then to remove the original lesions while reducing the number of implants, which reflects the continuous pursuit of people from restoring the vascular lumen patency to maintaining the patency of the lumen, and then to maintain the patency of the lumen and restore the vascular function at the same time It is not only the improvement of anatomical structure but also the restoration of vascular function.
Therefore, the general trend of the development of lower extremity arterial occlusive disease is to restore the anatomical structure before the disease, that is, to open the true lumen of endovascular surgery; the other is not to interfere with the physiological function of the blood vessel itself, that is, to maintain the vasomotor function. It is from the treatment of primary lesions, the removal of proliferative lesions (volume reduction) to the reduction of stent placement requirements, the emergence of DCB, biodegradable stents and other new devices.
In terms of clinical evidence, a systematic review of 2406 subjects from 13 studies in the United States and Germany shows that the incidence of target lesion revascularization (TLR) of DCB and DES is lower than that of bare metal stents and PTA, and it can save medical costs in the long run.

Causes of Unstable Concentration of Coating Drugs Reaching Target Lesion
However, DCB also has limitations, including ineffective treatment of severe calcification; the use of drugs to inhibit intimal hyperplasia is cytotoxic; and the concentration of coated drugs reaching the target lesion is unstable. There may be two reasons for the instability of drug concentration reaching the target lesion: one is that the bare delivery of drug balloon varies with the route (length and twist) of host vessel and blood flow velocity; the other is affected by the operation technology of the operator. If the drug coating can be reduced in vitro operation and delivery process, and the effective drug can be delivered to the target lesion, the concentration of drug coating can be appropriately reduced, to reduce the toxic reaction of patients.

Proposed Solutions
Professor Xu Xin of Fudan University Central Hospital proposed three methods to make DCB drug coating only act on target lesions: 1. Establish a reasonable surgical pathway; 2. At present, the working distance of balloon is 135 cm, which is delivered to the target lesion under the protection of 90 cm long sheath, and the longest drug coating is 30 cm after subtracting 45 cm naked operation distance. This method makes transportation smoother and reduces the drug coating falling off. It is feasible in the current practical operation, but it has little effect on the distal embolization. 3. Making the external protection system of the balloon, that is, retracting the protective sleeve when the balloon reaches the target lesion, and then opening the balloon. However, the three-layer structure has strict requirements for existing engineering technology.

(source:https://www.kossel-medical.com/how-to-optimize-the-use-of-drug-coated-balloon-in-peripheral-arterial-disease/)