Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.

开始日期2025-04-01

申办/合作机构

Shockwave Medical, Inc.

NCT06332911 / Not yet recruitingN/A

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.
The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

开始日期2024-08-01

申办/合作机构

Shockwave Medical, Inc.

NCT06149650 / RecruitingN/A

Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study

CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.

开始日期2024-07-15

申办/合作机构

Shockwave Medical, Inc.

100 项与 Shockwave Medical, Inc. 相关的临床结果

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0 项与 Shockwave Medical, Inc. 相关的专利（医药）

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项与 Shockwave Medical, Inc. 相关的文献（医药）

2024-11-01·JACC-Cardiovascular Interventions

Coronary Sinus Narrowing for Treating Refractory Angina

Article

作者: van de Hoef, Tim P ; West, Nick E.J. ; van Kuijk, Jan-Peter ; Byrne, Jonathan ; de Silva, Ranil ; West, Nick E J ; Buschmann, Eva ; Banai, Shmuel ; Dupont, Matthias ; Verheye, Stefan ; van de Hoef, Tim P. ; Montorfano, Matteo

BACKGROUND:

Patients with refractory angina are often ineligible for revascularization and have poor quality of life despite optimal medical therapy. The coronary sinus (CS) Reducer (Shockwave Medical Inc) was safe and effective in the treatment of refractory angina in the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) randomized sham-controlled trial.

OBJECTIVES:

This study sought to perform the primary endpoint analysis of the complete REDUCER-I (An Observational Study of the Neovasc Reducer System) study cohort.

METHODS:

REDUCER-I is a nonrandomized, "real-world" study of patients with refractory angina treated with the CS Reducer conducted at 25 centers from 9 European countries. The primary effectiveness endpoint was an improvement in Canadian Cardiovascular Society (CCS) class at 6 months. The primary safety endpoints were major adverse cardiac events and device- or procedure-related serious adverse events through 30 days. Study follow-up is planned through 5 years with some interim 3-year analyses included here.

RESULTS:

From 2016 to 2023, 400 patients were enrolled, including 78.0% (312/400) male patients, 54.3% (216/398) with previous myocardial infarction, 73.6% (293/398) with previous revascularization, and 72.0% (280/389) CCS class III/IV. Major adverse cardiac event and serious adverse event rates were 1.6% (95% CI: 0.7-3.6) and 1.1% (4/371), respectively, with no deaths within 30 days. At 6 months, 69.8% (240/344) of patients improved by ≥1 CCS class. Six-minute walk distances improved by 34.1 ± 85.8 m at 6 months (P < 0.0001). Interim 3-year results showed CCS class and Seattle Angina Questionnaire quality of life improvements were sustained (P < 0.0001).

CONCLUSIONS:

The complete primary endpoint analysis of the REDUCER-I study shows patients with refractory angina were safely and effectively treated with the CS Reducer. Improvements in angina and quality of life appear sustained through 3 years.

2024-11-01·JOURNAL OF VASCULAR SURGERY

Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease

Article

作者: Sayfo, Sameh ; Shammas, Nicolas W ; West, Nick E.J. ; Shields, Ryan ; Siah, Michael ; Babaev, Anvar ; West, Nick E J ; Soukas, Peter ; Chandra, Venita ; Park, James ; Shammas, Nicolas W. ; Lansky, Alexandra J. ; Lansky, Alexandra J ; Armstrong, Ehrin

BACKGROUND:

Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core laboratory-adjudicated, prospective, multicenter, single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System.

METHODS:

Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events or postoperative death at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core laboratory-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through 2 years.

RESULTS:

A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. The mean target lesion length was 76 ± 65 mm, diameter stenosis was 78% ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core laboratory. After IVL, residual stenosis was reduced to 29%, and after optional postdilatation and/or stent implantation, to 26%. At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days.

CONCLUSIONS:

The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient quality of life, and wound healing, with minimal adverse events at 30-day follow-up.

2023-09-01·JACC. Cardiovascular interventions

Histology, OCT, and Micro-CT Evaluation of Coronary Calcification Treated With Intravascular Lithotripsy

Article

作者: Ghosh, Saikat Kumar B ; Sato, Yu ; Kawakami, Rika ; Finn, Aloke V ; Konishi, Takao ; Virmani, Renu ; Kawai, Kenji ; Hokama, Jason Y

BACKGROUND:

Although intravascular lithotripsy (IVL) has been an emerging novel option to treat vascular calcification, the specific effects on histology have not been systematically examined.

OBJECTIVES:

The authors examined the histologic effects of IVL on coronary calcified lesions from human autopsy hearts and evaluated the diagnostic ability of optical coherence tomography (OCT) and micro-computed tomography (CT) to detect calcium fracture as identified by the gold standard histology.

METHODS:

Eight coronary lesions were treated with IVL, and 7 lesions were treated with 10 atm inflation using an IVL catheter balloon without lithotripsy pulses (plain old balloon angioplasty [POBA]). OCT and micro-CT imaging were performed before and after treatment, and the presence of calcium fracture was assessed. The frequency and size of fractures were measured and compared with the corresponding histology.

RESULTS:

All 15 treated lesions were diagnosed as sheet calcium by histology. Histological evidence of calcium fracture was significantly greater in the IVL group compared with the POBA group (62.5% vs 0.0%; P = 0.01). Calcified lesions with fracture had a larger maximum arc degree of calcification (median 145.6 [IQR: 134.4-300.4] degrees vs 107.0 [IQR: 88.9-129.1] degrees; P = 0.01). Micro-CT and histology showed an excellent correlation for fracture depth (R² = 0.83; P < 0.0001), whereas OCT showed less correlation (R² = 0.37; P = 0.11). The depth of fractures measured by OCT were significantly shorter than with those measured by histology (0.49 [IQR: 0.29-0.77] mm vs 0.88 [IQR: 0.64-1.07] mm; P = 0.008).

CONCLUSIONS:

IVL demonstrated a histologically superior fracturing effect on coronary calcified lesions compared with POBA. OCT failed to identify the presence of some calcium fractures and underestimated the depth of fracture when compared with micro-CT.

153

项与 Shockwave Medical, Inc. 相关的新闻（医药）

2024-11-04

·PRNewswire

Shockwave Medical Unveils First Clinical Outcomes of New IVL Platform in Late-Breaking Presentation at VIVA 2024

Novel Intravascular Lithotripsy (IVL) catheter demonstrates ability to modify calcium safely, enabling treatment and crossing of tightly-stenosed lower limb lesionsTechnology has received U.S. FDA clearance for patients with peripheral arterial disease LAS VEGAS, Nov. 4, 2024 /PRNewswire/ -- Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced today the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). Despite the challenging nature of the calcified lesions studied, the 30-day results met both prespecified performance goals while showing a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters. The results, which helped support U.S. Food and Drug Administration clearance of the technology last month, were presented as a late breaker today at the annual Vascular InterVentional Advances (VIVA) meeting. Continue Reading Shockwave Javelin Peripheral IVL Catheter "The outcomes were exactly what we have come to expect from IVL studies – a strong safety profile with the low final residual stenosis that physicians would hope to achieve," said JD Corl, MD, FACC, FSCAI, Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital and Principal Investigator of FORWARD PAD Study.† "These new initial data are promising and pave the way for a new approach to the application of Shockwave IVL in our peripheral practices. With technologies now suited to safely address both crossable and uncrossable lesions, IVL has a unique opportunity to play an increasingly important role in optimizing outcomes for a wider set of patients with PAD." PAD affects more than eight million people aged 40 and older in the United States.1 People suffering from PAD have not only impaired quality of life but also increased risk of heart attack or stroke.2 Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year, and a 50% mortality rate at five years,3 worse than most forms of cancer. The Shockwave Javelin Peripheral IVL Catheter is a novel, non-balloon-based device that features a single 120-pulse lithotripsy emitter at the distal tip of the catheter. It is designed for use in sub-total occlusions or extremely narrowed vessels in which a wire will cross but devices will not. With this new platform, the sonic pressure waves expand spherically from the forward-shifted emitter beyond the tip of the catheter, allowing modification of the obstructive calcification that facilitates device crossing. The Shockwave Javelin Peripheral IVL Catheter met both prespecified safety and effectiveness endpoints, with a major adverse event rate of 1.1% at 30 days, and a technical acute procedural success rate of 99%. Additionally, at final angiography, angiographic complications were restricted to a single case of dissection with no reported perforations, abrupt vessel closure, distal embolization or no-reflow. The feasibility and IDE studies of the Shockwave Javelin IVL catheter, MINI S and FORWARD PAD, respectively, were prospective, multi-center, single-arm, angiographic core-lab adjudicated studies with similar inclusion and exclusion criteria. The studies enrolled 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions. The average lesion length was 77mm, and just under half of the target lesions were located below the knee, and over a third were chronic total occlusions. "Recognizing the risks that patients with difficult-to-cross lesions are exposed to with other treatment modalities, we're extremely optimistic about the role that Shockwave Javelin could play in offering an effective alternative crossing and treatment tool with a strong safety profile," said Nick West, MD, Chief Medical Officer at Shockwave Medical. "We look forward to learning more about the performance of the Shockwave Javelin IVL catheter as we add to the ongoing trial follow-up data with a limited market release of the device in the coming months." About Shockwave Medical Shockwave Medical, part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at . Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is part of Johnson & Johnson MedTech. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Neither of Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.as a result of new information or future events or developments. † Dr. Corl is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release. 1 2 3 Media Contact: Rachael Jarnagin [email protected] SOURCE Johnson & Johnson MedTech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-10-29

·Mass Device

Shockwave Medical completes enrollment in all-female IVL study

The Shockwave study aims to confirm the benefits of coronary intravascular lithotripsy (IVL) in women. Co-principal investigator Dr. Margaret McEntegart, director of Complex PCI and CTO programs at Columbia University Medical Center/NewYork-Presbyterian Hospital, completed the final enrollment during a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. The study, which includes 400 participants across 48 sites in five countries, is set to release primary endpoint results in 2025, with continued patient follow-up through three years. “The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions,” said McEntegart. “Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients.” Women comprise about a quarter of cardiovascular clinical trial participants, limiting gender-specific data essential for treatment advancements. Female patients undergoing PCI face a higher risk of procedural complications, emphasizing the need for targeted studies. “We are eager to analyze the data and share results next year, with a goal of helping to close the gap in treatment outcomes between men and women,” said Alexandra Lansky, Professor of Medicine, section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine and co-principal investigator of EMPOWER CAD. “EMPOWER represents a significant step forward in women’s heart health. We also look forward to seeing the participating female interventional cardiologists and clinical researchers in the study continue to take on clinical trial leadership roles in the years to come.” Most notably, 71% of enrolling sites are led by female principal investigators. “We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care,” Shockwave Medical Chief Medical Officer Nick West said. “This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”

临床研究AHA会议

2024-09-26

·药研网

强生关闭心血管和代谢药物部门

据外媒Endpoints 9月25日报道，强生正在逐步关闭其制药部门的心血管和代谢部门，该举动主要影响销售、营销和医学事务团队。这是强生继去年关闭传染病和疫苗部门后的第二次大规模重组。本次重组主要影响心血管部门的商业工作，而非研发。这一变化促使强生在全球范围内裁员，并剥离了许多疫苗和预防项目。心血管和代谢部门的核心产品是拜瑞妥（利伐沙班），这是强生与拜耳合作开发的抗凝药，曾是世界上最畅销的药物之一。但由于美国政府的医疗保险价格谈判，拜瑞妥的价格降低了62%。强生的医疗器械部门在心血管领域的业务未受影响，仍在积极进行相关收购和研发活动：今年8月份，强生将以6亿美元的预付款收购V-Wave。今年4月，强生份以131亿美元现金收购Shockwave所有流通股，该公司专注于开发钙化心血管疾病治疗的产品，并全球首推产品“冲击波球囊导管”。 2022年，强生公司以166亿美元收购了医疗设备制造商Abiomed。该公司的王牌产品为Impella心脏泵。 2023年9月，强生宣布品牌焕新，将旗下医疗科技和制药两大业务整合至强生（Johnson & Johnson）名下。其中，制药业务杨森更名为强生创新制药（Johnson & Johnson Innovative Medicine）。这家制药公司一直淡化其心血管和代谢业务，将研发重点缩小到三个治疗领域：肿瘤学、免疫学和神经科学。强生在2024年进行了多项收购和研发活动，包括收购Proteologix获得免疫学双抗资产、收购Numab获得IL-4R/IL-31双抗、收购Ambrx开发下一代ADC产品等。公司发言人表示，这是强生在复杂和快速变化的外部环境中适应和发展业务的必要举措。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信 wfj_GM 商务合作稿件征集点击了解详情往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

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100 项与 Shockwave Medical, Inc. 相关的药物交易

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100 项与 Shockwave Medical, Inc. 相关的转化医学

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