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DES vs. DCB for De Novo Artery Lesions: Cage Free I, A Large Scale RCT, Has Enrolled All Estimated Patients

450 days from February 2021 to April 2022

2,270 patients enrolled at 43 clinical centers across China

1,132 patients with swide® Drug Coated Coronary Balloon

1,138 patients with the 2nd generation Sirolimus Eluting

All Estimated Patients Have Been Successfully Enrolled

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On April 30, 2022, the enrollment  was successfully completed for Paclitaxel-coated Balloon for Treatment of De Novo Non – complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial (   CAGE-FREE I,  a randomized controlled trial ) . This randomized controlled trial (RCT) was initiated by Ling Tao M.D (  Professor in Cardiology, Director of the Department of Cardiology from Xijing Hospital of Air Force Medical University) , and sponsored by Shanghai Shenqi Medical Technology Co., Ltd. (hereinafter referred to as “Shenqi Medical”).  

In recent years, the concept of “leave nothing behind,” represented by Drug-coated Balloon (DCB) in the treatment of coronary artery lesions, has been increasingly recognized by interventional cardiologists. DCB is a novel treatment strategy for coronary artery lesions based on The fast and homogeneous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Compared with DES, DCB allows better restoration of the vessel’s physiological function and precludes permanent implants, thus diminishing the likelihood of foreign body reaction.

In light of the EBM, the efficacy of DCB treatment strategy has been increasingly recognized. As recommended by the European Society of Cardiology guidelines, the level of evidence of DCB treating ISR is IA. However, DCB’s efficacy in treating de novo coronary artery lesions remains Controversial. Although the safety and effectiveness of DCB in the treatment of de novo small-vessel diseases has been substantiated by the  BASKET-SMALL 2 Trial  published in  The Lancet  in 2018, there is no large-scale RCT comparing the clinical outcomes of DCB versus DCB DES in large vessels with de novo lesions. Therefore, the effectiveness of DCB-only strategy in the treatment of large vessels with de novo lesions has become a clinical issue in needs of interventional cardiologists’ exploration.

The Results of the RCT May Fill in the Gaps in Including De Novo Lesions To DCB’s Indications

The enrollment for CAGE-FREE I was initiated in February 2021. The RCT is intended to evaluate whether the efficacy of Paclitaxel-coated balloon is non-inferior to that of Sirolimus-eluting stent for the treatment of de novo non-complex coronary artery lesions . The primary endpoint is a 24-month Device-oriented Composite Endpoint (DoCE), which is a composite clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). All patients will be followed up continuously for 24 months after the enrollment.

At present, a total of 2,270 patients have been successfully enrolled at 43 clinical centers across China. The enrolled patients are those with indications for PCI due to acute or chronic coronary syndrome, with de novo non-complex lesions, and have undergone successful pre- dilation. All patients were randomized by the clinical centers in a parallel assignment when the RCT entered clinical study phase. 1,132 patients were implanted with Shenqi Medical’s DCB, swide®, whereas the other 1,138 patients were implanted with the 2nd generation Sirolimus-eluting stents. The patients have an average age of 61, 69% male, 26% with diabetes mellitus, and 60% with hypertension. During the PCI, 35%, 35% and 42% of the patients were pre-dilated with scoring balloons, cutting balloons and non-compliant balloons respectively.The mean diameter of the implanted DCBs is 3.13 mm.

As the first large scale RCT with a clinical “hard endpoint” in the treatment of de novo large-vessel lesions, the results of  Cage-Free I  are expected to provide EBM for the efficacy of DCB-only treatment in de novo non-complex lesions, demonstrating and popularizing the latest concept of “leave nothing behind.”

Shanghai Shenqi Medical Technology Co., Ltd. (Shenqi Medical) is a high-tech enterprise founded in 2014 and headquartered in Shanghai Zhangjiang Hi-Tech Park. Shenqi Medical is dedicated to R&D, manufacturing, and sales of innovative medical devices, offering a comprehensive product portfolio providing solutions for cardiovascular, structural heart disease, peripheral, and neurovascular medical devices in China. Shenqi Medical has also invested in Beijing HeartCare Medical Technology Co., Ltd. (Beijing HeartCare), the first Chinese company to develop heart failure ultrafiltration equipment.

Deeply rooted in China, Shenqi Medical has long been committed to “innovation for cardio health.” With the mission of “satisfying the rapidly-growing needs arising from China market,” Shenqi Medical will continue to strengthen research and development capabilities and expand the product portfolio, providing comprehensive and high-quality solutions for Chinese patients.

All Estimated Patients Have Been Successfully Enrolled  in

CAGE-FREE I at 43 Clinical Centers in 27 Cities Across China

This article is only for reference by healthcare professionals and does not constitute any medical advice;

Any information of this article can only be reprinted upon authorization and with the source indicated.

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[Leaving Nothing Behind] Drug-coated Balloons for Coronary Artery Disease: From Consensus to Application

Shenqi Medical @ 2022 SCC

The 23rd South International Congress of Cardiology Malaysia (SCC 2022) (, jointly sponsored by Guangdong Medical Association, Guangdong Society of Interventional Cardiology, and Guangdong Pharmaceutical Association, was successfully held from April 12 to April 17, 2022. Numerous renowned cardiologists at home and abroad gathered at the congress, passionately discussing the latest techniques, concepts, and advances in the cardiology field.

17 live broadcast rooms were set up and 27 seminars were convened as parallel sessions during this year’s SCC

During the congress, 17 live broadcast rooms were initiated and 27 academic forums were launched as parallel sessions. The presence of the distinguished cardiologists profoundly enriched the connotation of the meticulously designed thematic forums. The thematic speeches delivered by the cardiologists reached a total of 673 person-times, hitting a new peak at the SCC 2022. Presided over by 513 person-times and discussed and summarized by 173 person-times, the forums won 293,176 clicks and 169,427 actual viewers, achieving a total viewing time of up to 1,845,711 minutes.

Dr. Jianfang Luo and Dr. Bin Li leading the discussion of the Third Report of the International DCB Consensus Group and the future perspective of DCB
Dr. Bin Liu, Dr. Xiaojun Bai, and Dr. Yuanwen Qin leading the discussion of the importance of lesion preparation and related topics
Dr. Chunguang Qiu, Dr. Changjie Ren, and Dr. Liangqiu Tang leading the discussion of DCB indications and clinical practical experience of DCB applications in bifurcation lesion, de novo lesion, and ACS

Shanghai Shenqi Medical Technology Co., Ltd. Malaysia (hereinafter referred to as “Shenqi Medical”) has been endeavoring in the cardiology field since its founding date, and sparing no efforts to popularize the application of DCB and the concept of “leaving nothing behind”. During the congress, Shenqi Medical invited 16 Chinese top interventional cardiologists to its thematic forum to deliver comprehensive discussions on the latest EBM and clinical applications of DCBs.

The Third Report of the International DCB Consensus Group (2022) has shown other emerging indications for DCBs

Dr. Hongwei Pan introducing the advantages of DCB treatment

The Third Report of the International DCB Consensus Group Malaysia (2020) points out that DCBs can also be extensively applied in patients suffering from various coronary artery diseases (including large-vessel disease, small-vessel disease, bifurcation lesions, and de novo lesions) complicated with diabetes mellitus, high bleeding risk and ACS, besides their initial application for the treatment of ISR lesions.

– PAN Hongwei, M.D., Hunan Provincial People’s Hospital (the First Affiliated Hospital of Hunan Normal University) [a medical expert of Coronary Artery Disease Group of Quality Control Committee, the National Center for Cardiovascular Diseases (NCCD)]

Given sufficient lesion preparation, the efficacy of DCB is no-inferior to that of DES in treating STEMI patients.

Dr. Jun Jiang sharing the evidence-based development path of DCB in treating STEMI

The safety and effectiveness of DCB and DES in STEMI patients have been compared in the REVELATION Trial (a prospective, single-center, and randomized controlled trial) with the 9-month follow-up FFR as the primary endpoint, showing that the efficacy of DCB is no-inferior to that of DES in STEMI patients when sufficient lesion preparation was given prior to DCB treatment. Such conclusion has also been convincingly supported by the PEPCAD NSTEMI Trial.

PEPCAD NSTEMI Trial: Clinical events at 9-month follow-up. Treatment per protocol (DCB only vs stent only)

– JIANG Jun, M.D., the Second Affiliated Hospital, Zhejiang University School of Medicine [a fellow of the American College of Cardiology (FACC)]

Sufficient lesion preparation is crucial to maximizing the efficacy of DCB treatment, the effect of which can be improved with the aid of multiple auxiliary devices

Dr. Xiufeng Zhao highlighting the importance of lesion preparation in maximizing the efficacy of DCB treatment

Sufficient lesion preparation is crucial to maximizing the efficacy of DCB treatment. The Third Report of the International DCB Consensus Group (2020) points out that the following factors must be simultaneously met prior to DCB treatment: ≤30% residual stenosis, type C or below dissections, and TIMI flow grade 3.

Contrasting images of before and after DCB treatment with cutting balloon:

Pre-IVUS LCX: middle segment stenosis
2.5*10mm Wolverine Cutting Balloon, 10atm*5s; 2.5*15mm swide DCB, 12atm*60s

Regarding DES-ISR, the lesion preparation performed by a cutting/scoring balloon will increase lumen diameter and lower restenosis rate.

Regarding the de novo small-vessel disease with a high restenosis rate and prone to acute vessel closure and dissection, the lesion preparation performed by a cutting/scoring balloon will lower the risk of dissection and increase the late lumen enlargement.

Regarding bifurcation lesions, the lesion preparation performed by a cutting/scoring balloon will reduce the elastic recoil and plaque/carina shift.

– ZHAO Xiufeng, M.D., Handan First Hospital [a national member of the Cardiology Branch of Medical Device Management Committee (MDMC), China Medicine Education Association (CMEA)]

Intracoronary imaging technique is an important tool to evaluate the lesion preparation effect.

Dr. Ximing Chen strengthening the clinical value of intravascular imaging technique

The application of intracoronary imaging is beneficial for doctors to define the lesion characteristics, evaluate the lesion nature, determine the lesion preparation devices, select DCBs with appropriate sizes, and observe the immediate efficacy of DCB treatment, thus achieving more optimal treatment outcomes.

Regarding small-vessel disease, IVUS imaging should be performed prior to pre-dilation to determine whether the pre-dilation is necessary.

Regarding lesions requiring pre-dilation, procedures should involve selecting appropriate balloons according to IVUS measurement parameters and evaluating the presence of any dissection afterwards.

Regarding bifurcation lesions, intracoronary imaging should be performed to evaluate whether the side branch ostial lesion is affected after the main branch stent implantation, so as to avoid DCB treatment failure.

– CHEN Ximing, M.D., the Third Affiliated Hospital of Guangzhou Medical University [a visiting scholar at Cardiac Intervention Center in Portland, Oregon, the United States]

In recent years, the concept of “leaving nothing behind” has been increasingly recognized by both doctors and patients. The unique advantages of DCB treatment includes mitigating the impact on coronary artery anatomy by avoiding overlapped stent implantation for ISR lesions, lessening delayed endothelialization by ensuring uniform drug coating, lowering the risk of late thrombosis by excluding the multipolymers that are applied on DES, and reducing expenses by shortening DAPT courses To sum up, as a novel therapeutic strategy more flexible to operate, DCB treatment could be a promising alternative for the treatment of lesions such as small-vessel disease, tortuosity, and bifurcation in patients with poor DES-treament outcomes.

For more information, you can contact us [email protected].


[1] Belkacemi, Anouar, Agostoni, et al. First Results of the DEB-AMI (Drug-Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial [J]. Journal of the American College of Cardiology, 2012.

[2] Vos N S, Fagel N D, Amoroso G, et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial – Science Direct[J]. JACC: Cardiovascular Interventions, 2019, 12( 17):1691-1699.

[3] Jeger R V, Eccleshall S, Wan A, et al. Drug-Coated Balloons for Coronary Artery Disease[J]. JACC Cardiovascular Interventions, 2020, 13(12).

[4] Bruno S, Marc-Alexander O, Sebastian E, et al. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomized PEPCAD NSTEMI trial[J]. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 15(17):1527-1533.

[5] Weisz, Metzger, Liberman, et al. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch [J]. Catheterization and Cardiovascular Interventions, 82:352- 359 (2013).

This article is only for reference by healthcare professionals and does not constitute any medical advice;

Any information of this article can only be reprinted upon authorization and with the source indicated.

PCCS finds better fit in the healthcare industry

PCCS Group Bhd Malaysia has long been known as a garment manufacturer and a label maker, but as the second generation of the family-run business takes over, the focus of the group is beginning to change.

With nearly five decades of experience in making apparels, PCCS Malaysia has been a supplier to many brands including Puma, Adidas, Li-Ning, H&M and Decathlon. Apart from Malaysia, the group’s garment business is also present in China and Cambodia.

PCCS Malaysia is also one of the largest label and packaging makers in Malaysia, via its subsidiary Mega Label (M) Sdn Bhd Malaysia, which was established in 1987.

Supported by these two businesses, the group has been making over RM400mil-RM500mil in annual sales, but the turnover has been declining in recent years.

The group was not spared from the impact of the Covid-19 pandemic and has recorded losses in the past two quarters.

For the first nine months ended Dec 31,2020, PCCS Malaysia reported a net loss of RM2.81mil as compared to a net profit of almost RM6mil a year earlier.

The main issue with PCCS Malaysia is that its biggest revenue contributor – garment manufacturing – only delivers low single-digit net profit margins.

The label and packaging business, on the other hand, has been loss-making.

Group managing director David Chan Wee Kiang, who was promoted to the position in November 2020, acknowledges that PCCS’ low-margin conditions have affected the group’s earnings trajectory.

Wee Kiang is the eldest son of PCCS founder and single largest shareholder Chan Choo Sing.

Choo Sing is also currently the executive chairman of PCCS. The Chan family controls over 40% of PCCS.

Looking ahead, Wee Kiang believes that the group needs a new growth strategy.

“Diversification is the only answer, especially into high-margin businesses that deliver stable earnings, ” he tells StarBizWeek.

Hence, it is no surprise that PCCS Malaysia has announced the venture into new business segments since last year, namely, medical device distribution and hire purchase financing.“Both businesses would be able to give the group commendable net profit margins of 20% to 30%, as compared to the group’s current margin of below 5%.

“They will also be the main revenue contributors to PCCS Malaysia in the future. Within the next couple of years, the medical device segment is expected to deliver over 30% to the bottom line, while the hire purchase business could contribute about 20%.

“Nevertheless, I remain committed to the group’s existing businesses, ” he says.

In April this year, PCCS said it will be investing RM4mil to enter into the used vehicle financing and insurance business, focusing on the Johor and Melaka markets.

This business will be undertaken via Southern Auto Capital Sdn Bhd, a joint venture company in which PCCS Malaysia holds 80% interest.The balance 20% stake is owned by Justin See Kok Wah, who is an adviser to 365 Capital Sdn Bhd, a company principally engaged in the business of used cars financing.

Wee Kiang says the group wants to capitalise on See’s long-built experience in the second-hand vehicle financing and auto insurance business.

“We believe that the used car financing segment is under-tapped in Malaysia, hence we want to capitalise on the available market opportunities. The hire purchase business is expected to deliver its first profit in the first quarter of 2022, ” he adds.

As for the medical device distribution business, which was first announced in December 2020, Wee Kiang says it will take about two years to generate revenue and deliver its first profit.“For us to distribute medical devices, we need to first obtain approvals from respective medical device regulators in the markets we intend to penetrate.

“The approval process will typically take one to two years, depending on the jurisdictions, ” he says.

Last week, PCCS, via its subsidiary La Prima Medicare Pte Ltd Malaysia, entered into an exclusive agreement with Shanghai Shenqi Medical Technology Co Ltd to distribute the latter’s medical devices within Asia-Pacific, excluding China and Japan.

The agreement will be in effect until May 21,2023, and La Prima has the right to extend the agreement for a further two years.

The agreement allows PCCS Malaysia to distribute Shenqi’s medical devices related to cardiology or heart-related diseases.

These include medical diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology.

Founded in 2014, China-based Shenqi is primarily engaged in the development of minimally invasive surgery products and devices, enabling safer and more reliable cardiovascular surgeries. Its products are primarily designed for cardiovascular interventional and peripheral vascular interventional procedures.

“We are already in the process of getting Shenqi’s products registered in some of the Asean countries. We will make the relevant announcements when necessary, ” he says.

Given the rising cardiovascular diseases across the world, including among the younger population, Wee Kiang says this has created a huge market for innovative and niche medical devices.

“PCCS hopes to ride on this demand, in partnership with Shenqi.

“We aren’t just another company jumping into the medical bandwagon. We are serious about growing the medical business for PCCS, ” says Wee Kiang.

He also points out that among the initial products that would be distributed by PCCS is Shenqi’s self-developed drug-coated balloon (DCB) catheter.

The DCB catheter is an alternative to drug-eluting stents that are used to treat coronary artery disease. The product was registered with China’s National Medical Products Administration in December 2019.

Wee Kiang describes the DCB catheter as a “star product” of Shenqi in China, given the huge demand. He expects to replicate the success by introducing the DCB catheter to the Asia-Pacific markets.

In addition to the medical device distribution business, Wee Kiang says PCCS is working on developing its own medical devices.

“The research and development works are still ongoing, hence I could not provide more details. But once everything is finalised, this will be another good revenue stream for the group with higher margins as the products are developed in-house, ” he adds.

Wee Kiang’s ambition to turn PCCS into a diversified group is supported by its balance sheet. As of end-December 2020, the group sits on a net cash position, with almost RM60mil in cash and cash equivalents against RM53.1mil in total borrowings.

Its gearing ratio of 29%, which Wee Kiang describes as optimal, would also allow PCCS to seek bank financing when necessary.

This provides the group ample room to expand organically and inorganically over the longer term.

If you would like to have more information, you can contact [email protected].

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Shenqi appoints PCCS as exclusive distributor for APAC

PCCS Malaysia managing director David Chan Wee Kiang said this agreement marks the first step of PCCS in the medical and healthcare sector towards a long-term strategic cooperation with STM.

KUALA LUMPUR: PCCS Group Bhd’s (PGB) wholly-owned subsidiary, La Prima Medicare Pte Ltd (LPM) Malaysia inked an exclusive distribution agreement with China-based Shenqi Medical Technology Co Ltd’s (SMT) Malaysia medical products within the Asia-Pacific region.

In this agreement, LPM is the exclusive distributor for SMT’s medical products, namely the drug coated balloon within the Asia Pacific, excluding China and Japan.

The term of the agreement shall commence on May 22, 2021 until May 21, 2023.

PCCS Malaysia managing director David Chan Wee Kiang said this agreement marks the first step of PCCS Malaysia in the medical and healthcare sector towards a long-term strategic cooperation with STM.

“The agreement we signed today is a result of many years of groundwork, research and trials.

“We aren’t just another company jumping into the medical bandwagon. We are serious about growing the medical business for PCCS Malaysia,” said Chan in a statement today.

LPM was incorporated in Singapore on June 26, 2020, and is principally engaged in the wholesale of medical, professional, scientific and precision equipment.

Founded in 2014, STM is primarily engaged in the development of minimally invasive surgery products and devices, enabling safer and more reliable cardiovascular surgeries.

Its products are primarily designed for cardiovascular interventional and peripheral vascular interventional procedures.

STM’s current star product in China is its drug-coated coronary balloon catheter which has obtained the National Medical Products Administration (NMPA) registration certificate in December 2019.

“We are already in the process of getting STM’s products registered in some of the South East Asian countries. We will make the relevant announcements when necessary,” said Chan.

This agreement will not have any material effect on the earnings of PCCS Malaysia for the financial year ending March 31, 2022.

STM has completed several rounds of investments from reputable investors since its inception

These include Hillhouse Capital Group, LYFE Capital, 3H Health Investment and Hardy Farm Ventures among others.

Please feel free to contact [email protected] if you need any further information.

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PCCS teams up with Shenqi Medical to seek a grand blueprint of medical health in Asia-Pacific

Shanghai, China (Dec 15): PCCS Group Bhd Malaysia (PCCS) and China’s Shanghai Shenqi  Medical Co, Ltd (Shenqi) today announced the signing of a memorandum of  understanding (MoU) to cooperatively pursue healthcare business opportunities within Asia-Pacific. The partnership is intended to develop the commercialisation of cardiology-related medical device technologies by leveraging the strengths of both companies: Shenqi’s capability in developing innovative medical devices complements PCCS’s Malaysia capabilities, experience and reach within the Asia-Pacific market. This cooperation will also enable PCCS Malaysia to strategically position itself in the medical and healthcare sectors.

“As a hi-tech medical device enterprise, we have been focusing on the research of high-value medical consumables since our establishment. We sincerely hope that more patients with cardiovascular diseases will benefit from the innovative products developed by Shenqi. In August this year, we also completed a series C financing of several hundred million yuan to further develop and market our existing products,” said Dai ZhiHao, spokesperson of Shenqi. “PCCS Malaysia has been profoundly involved with conducting businesses within the Asia-Pacific region for many years … Therefore, having a profound understanding and strong influence over many different market segments within the Asia-Pacific region. With the help of its market influence, we hope to  promote our overseas market layout through its contacts, channels, public relations,  mature management team and market penetration, so that the medical technology  ‘created in China’ will go abroad and benefit the patient groups in the Asia-Pacific region and even other regions.”

“In recent years, China’s medical and health technology has been developing rapidly. We are very optimistic about its rapidly evolving scientific research capabilities and have been looking for exceptional business partners. Shenqi’s corporate core values, strong product development and innovation strength matches our corporate development philosophy and strategic designs. We are honoured to have such an in-depth cooperation with Shenqi to help expand their product application market,” Chan Wee Kiang, spokesperson of PCCS Malaysia, said at the signing ceremony. “As a diversified international trading and investment company, PCCS hopes to create a better world through investment. We are also exceptionally honoured to be a bridge for the trades between China and the Asia-Pacific region, and to also support Chinese companies to further explore and achieve mutual benefits, obtaining a win-win situation.”

This cooperation is the first step taken by PCCS to venture into the medical and healthcare industry, and to also initiate a long-term strategic cooperation with Shenqi. In the future, the two parties will delve deeper into the medical and healthcare field to undertake more diversified and in-depth cooperation.

Investors can refer to PCCS’s Bursa Announcement for further information.

 If you require any further information, feel free to contact [email protected].

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