News Article | November 29, 2016
DURHAM, North Carolina, Nov. 29, 2016 /PRNewswire/ -- Micell Technologies, Inc. (Micell) announced enrollment of the first patient in DESSOLVE J: a prospective, randomized, balanced, controlled, double-blind, multi-center study comparing MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) to XIENCE V Everolimus Eluting Coronary Stent System (Xience) in Japan. Shigeru Saito, M.D., Vice Director, Shonan Kamakura General Hospital and Director of Cardiology and Catheterization Laboratories, is the principal investigator. DESSOLVE J is an all-comers trial with a primary endpoint of target lesion failure (TLF) comparing 12-month clinical outcomes between MiStent and Xience. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes and those who qualify for percutaneous coronary interventions. Enrollment is planned at approximately 10 clinical sites throughout Japan. "We are pleased to enroll the first patient in this important study," said Dr. Saito. "This study is a historic one for Japan. It will provide us with valuable insights into the potential benefits of MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus." DESSOLVE J is intended to provide Japanese-specific data that is supportive of DESSOLVE III, an all-comers clinical study that includes 1,400 patients randomized to MiStent or Xience at 20 sites in Europe. DESSOLVE III completed enrollment in 2015. Following the completion of DESSOLVE J, Micell intends to file a pre-market approval application with Japan's Pharmaceuticals and Medical Devices Agency for approval by its Ministry of Health, Labour, and Welfare. Micell's patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system -- a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility. Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell said, "Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed. Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement that could provide clinicians and patients worldwide with enhanced treatment options." MiStent is designed to optimize healing and clinical performance in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents and improve long-term clinical outcomes. EU approval of MiStent was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent to Xience Everolimus Eluting Coronary Stent System® (Xience). DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent and Xience in a "real world, all-comers" patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint for this trial is a non-inferiority comparison of target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017. MiStent has received CE marking, but is not approved for sale in the United States. This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of MiStent in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of, and expectations about, future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to, the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release. Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.
News Article | February 20, 2017
ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today released 1-year results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2017 Cardiovascular Research Technologies (CRT) conference in Washington, D.C. The COAST study is CSI’s prospective, single-arm, multi-center, global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions. It follows the pivotal ORBIT II trial of the company’s Diamondback 360® Coronary OAS Classic Crown, which received PMA approval from the U.S. Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery. CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015. Dr. Samin K. Sharma, Mount Sinai Medical Center, N.Y., presented the 1-year results including freedom from major adverse cardiac events (MACE), as well as target lesion revascularization (TLR) at one year after the procedure. Additional authors on the abstract are: Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Japan; Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, N.Y.; and Dr. Gregg Stone, Columbia University Medical Center, N.Y. “Incidence of severe coronary arterial calcium is significant and underappreciated,” said Dr. Sharma. “These 1-year results from the COAST IDE Study resulted in 77.8% freedom from 1-year MACE, therefore concluding that the Diamondback 360° Coronary OAS Micro Crown technology may address this unmet treatment need for this difficult to treat population.” Said Scott Ward, CSI chairman and chief executive officer, “We look forward to seeing how this 1-year COAST data will further impact the treatment of patients with severe coronary arterial calcium. It is important and necessary as we continue to seek device approval in the U.S. and Japan.” More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT02132611. About Coronary Artery Disease (CAD) CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE). About Cardiovascular Systems, Inc. Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 290,000 of CSI’s devices have been sold to leading institutions across the United States. The Coronary OAS Micro Crown is limited by federal law to investigational use and is currently not commercially available in the United States. For more information, visit the company’s website at www.csi360.com.
Takeshita S.,Shonan Kamakura General Hospital |
Takagi A.,TERUMO Corporation |
Saito S.,Shonan Kamakura General Hospital
Catheterization and Cardiovascular Interventions | Year: 2012
Background: We previously proposed a technique called the "mother-child technique" to facilitate stent delivery for complex coronary lesions. This technique is applicable when the backup support of the guiding catheter is insufficient. In this study, we used an in vitro coronary artery tree model to determine the impact of the size of the mother guiding catheter on the backup support of the mother-child guiding system. Methods: The backup support was measured for the 4-in-5, 4-in-6, 4-in-7, and 4-in-8 systems as well as for the 5-in-6, 5-in-7, and 5-in-8 systems. Results: Advancement of the child catheter into the coronary artery tree model improved the backup support of the mother-child system. When a 4-Fr child catheter was advanced by 9 cm, the relative increase in the backup support was 174% in the 4-in-5 system; it was 203% in the 4-in-6, and 135% in the 4-in-7 system (P < 0.05 vs. the mother catheter alone). The relative increase with the 5-Fr child catheter was 289% in the 5-in-6 system, and 152% in the 5-in-7 system (P < 0.0001 vs. the mother catheter alone). However, the improvement in the backup support with 9-cm child catheter advancement did not reach statistical significance for either the 4-in-8 (115%) or the 5-in-8 (112%) system (P = NS). Conclusions: The relative increase in the backup support of the mother-child system was inversely related to the size of the mother guiding catheter. Thus, the mother-child technique may be most useful for PCIs in which a small guiding catheter is used, such as transradial coronary interventions. © 2011 Wiley Periodicals, Inc.
News Article | December 1, 2016
DUBLIN - Dec. 1, 2016 - Medtronic plc (NYSE: MDT) today announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve(TM) Evolut(TM) R System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with transcatheter aortic valve implantation (TAVI) is determined to be the best option. This approval follows the Shonin approval from the MHLW the company received in November. The approval is based on robust data from the CoreValve U.S. Pivotal and CE Mark Clinical Trials, which demonstrated high rates of survival, low rates of stroke and excellent hemodynamics. Designed to treat patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body, the CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 120,000 patients in 60 countries. "TAVI continues to grow as an established treatment for inoperable AS patients in Japan and we are excited to have a next-generation, self-expanding option, as the Evolut-R system has demonstrated exceptional clinical results in studies globally," said Yoshiki Sawa, M.D., professor in the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan. "Clinical data show the advancement of recapturability with Evolut R gives physicians more confidence during the procedure, providing different advantages not currently available in other TAVI systems." The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo(TM) R Delivery System, which features an Enveo R InLine(TM) Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch). The Evolut R System, with its self-expanding nitinol frame, is designed to optimally fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance. "Heart teams made up of cardiac surgeons and interventional cardiologists in Japan are making important TAVI treatment decisions for patients who may benefit from this less invasive valve replacement procedure, and now having the option to recapturable and reposition will only help to improve patient outcomes," added Shigeru Saito, M.D., director of cardiology and catheterization laboratories at Shonan Kamakura General Hospital in Kamakura, Japan. Based on the knowledge gained through extensive experience with the CoreValve System, the Evolut R is intended to increase conformability and sealing at the annulus. An extended sealing skirt on the 26mm and 29mm valve sizes is intended to further promote valve sealing at the annulus. "This approval stems from our global commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting Japanese heart teams as they look to next-generation technologies to improve valve performance for a broad range of patients," said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, which is part of the Cardiac and Vascular Group at Medtronic. "We look forward to introducing this next-generation, recapturable technology to indicated patients in Japan." The CoreValve System was the first self-expanding TAVI system to be approved in Japan in March of 2015. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Tsuburaya A.,Shonan Kamakura General Hospital |
Mizusawa J.,Clinical Data |
Tanaka Y.,Saitama Cancer Center |
Fukushima N.,Yamagata Prefectural Central Hospital |
And 2 more authors.
British Journal of Surgery | Year: 2014
Background Locally advanced gastric cancer with extensive regional and/or para-aortic lymph node (PAN) metastases is typically unresectable and associated with poor outcomes. This study investigated the safety and efficacy of S-1 plus cisplatin followed by extended surgery with PAN dissection for gastric cancer with extensive lymph node metastasis. Methods Patients with gastric cancer with bulky lymph node metastasis along the coeliac artery and its branches and/or PAN metastasis received two or three 28-day cycles of S-1 plus cisplatin, followed by gastrectomy with D2 plus PAN dissection. The primary endpoint was the percentage of complete resections with clear margins in the primary tumour (R0 resection). A target sample size of 50 with one-sided α of 0·105 and β of approximately 0·2 corresponded to an expected R0 rate of 65 per cent and a threshold of 50 per cent. Results Between February 2005 and June 2007, 53 patients were enrolled, of whom 51 were eligible. The R0 resection rate was 82 per cent. Clinical and pathological response rates were 65 and 51 per cent respectively. The 3- and 5-year overall survival rates were 59 and 53 per cent respectively. During chemotherapy, grade 3/4 neutropenia occurred in 19 per cent and grade 3/4 non-haematological adverse events in 15·4 per cent. The incidence of grade 3/4 adverse events related to surgery was 12 per cent. There were no reoperations or treatment-related deaths. Conclusion For locally advanced gastric cancer with extensive lymph node metastasis, 4-weekly S-1 plus cisplatin followed by surgery including PAN dissection was safe and effective for some patients. Further investigation of this treatment strategy is warranted. Merits confirmation in a Western population © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.
Saito S.,Shonan Kamakura General Hospital
Current Treatment Options in Cardiovascular Medicine | Year: 2011
Opinion Statement: You have a consultation from a 67-year-old patient with severe effort angina. Full-dose prescription could not relieve his symptoms. He had bypass surgery (coronary artery bypass graft [CABG]) more than 10 years ago. Saphenous vein graft (SVG) to a big right coronary artery (RCA) was recently occluded. SVG to a small circumflex artery was occluded before. Left internal mammary artery graft to left anterior descending artery was nicely patented. His native RCA has been occluded since before he received CABG. How can we treat these patients? Among the treatment options between redo CABG and percutaneous coronary intervention (PCI) for the chronic total occlusion of his native RCA, I propose choosing the latter option. © 2010 Springer Science+Business Media, LLC.
Iwata T.,Shonan Kamakura General Hospital |
Mori T.,Shonan Kamakura General Hospital |
Tajiri H.,Shonan Kamakura General Hospital |
Nakazaki M.,Shonan Kamakura General Hospital
Neurosurgery | Year: 2011
Background: Hyperperfusion syndrome (HPS) is a critical complication after carotid artery stenting (CAS) and carotid endarterectomy (CEA). Objective: To identify predictors of HPS before and immediately after CAS. Methods: We analyzed patients who underwent elective CAS from 2005 to 2008, and underwent single-photon emission computed tomography (SPECT) and transcranial color-coded real-time sonography before and immediately after CAS. HPS was defined as post-CAS deteriorating neurological conditions with headache not secondary to cerebral ischemia. We assessed the measures of blood flow between the two cortical hemispheres by taking the ratio of cerebral blood flow (CBF) of the affected to unaffected hemisphere excluding any ischemic/infarcted areas (asymmetry index); the measures of blood flow within each cortical hemisphere by comparing the CBF in the affected cortical hemispheric area to the CBF in the ipsilateral cerebellar hemisphere (middle cerebral artery [MCA]-to-cerebellar activity ratio); cerebral vasoreactivity (CVR); MCA mean blood flow velocity in the affected hemisphere; and MCA mean blood flow velocity ratio (preoperative to postoperative). Results: Sixty-four patients were analyzed retrospectively. Nine patients presented with HPS. Logistic regression analysis showed that CVR (P < .01) and MCA mean blood flow velocity (P < .05) were the significant predictors among the pre-CAS variables, and that MCA mean blood flow velocity ratio (P < .05) and MCA-to-cerebellar activity ratio change (P < .05) were significant predictors among the post-CAS variables. Conclusion: SPECT and transcranial color-coded real-time sonography studies are useful in predicting HPS. Copyright © 2011 by the Congress of Neurological Surgeons.
Iwata T.,Shonan Kamakura General Hospital
Clinical Neurology | Year: 2014
Recently, remarkable progress has been made in the field of endovascular treatment, and endovascular treatment for acute ischemic stroke due to large vessel occlusion has been an effective and therapeutic option. However, there is no randomized control trial as to superiority of endovascular treatment for acute ischemic stroke compared to the standard treatment including intravenous rt-PA. Inclusion criteria for the performance of endovascular treatment for acute ischemic stroke will need to be defined more precisely, and high rates of fast recanalization will be needed in future. We expect the evidence that endovascular treatment for acute ischemic stroke due to large vessel occlusion is superior to standard treatment by the detailed images of the brain, more strict indications and novel endovascular devices such as percutaneous transluminal mechanical thrombectomy devices.
Takeshita S.,Shonan Kamakura General Hospital |
Tanaka S.,Shonan Kamakura General Hospital |
Saito S.,Shonan Kamakura General Hospital
Catheterization and Cardiovascular Interventions | Year: 2010
Objectives: We sought to determine whether 4-Fr percutaneous coronary intervention (PCI) is associated with technical difficulties that might have an unfavorable impact on procedural parameters. Background: Four-Fr PCI is often associated with difficulties in catheter manipulation, which may lead to greater time consumption and increased dye usage when compared with PCI employing larger guiding catheters. Methods: From July 2007 to March 2009, 62 patients underwent 4-Fr PCI. Procedural characteristics were compared between patients who underwent 4-Fr PCI in 2007 (early phase: 31 lesions in 26 patients) and those underwent in 2008 or later (later phase: 40 lesions in 36 patients). Results: Ad-hoc coronary intervention (3% vs. 23%, P < 0.05) and deepvessel intubation (46% vs. 91%, P < 0.05) were observed less frequently in the late phase than the early phase. Fluoroscopy time (8 6 6 min vs. 17 6 15 min, P < 0.05) and the amount of contrast dye used (64 6 33 mL vs. 90 6 46 mL, P < 0.05) were significantly reduced in the late phase than the early phase. No access site-related complications were observed in patients in either phase. Conclusions: The performance of 4-Fr PCI requires a certain learning curve, following which a reduction in fluoroscopy time and use of contrast dye may be achieved. This improvement in procedural parameters and the low incidence of access site-related complications might allow 4-Fr PCI to serve as a minimally invasive approach for the treatment of coronary artery diseases. © 2009 Wiley-Liss, Inc.
Okamoto K.,Shonan Kamakura General Hospital
BMJ case reports | Year: 2011
The authors report a case of a 43-year-old woman who presented with second degree chemical burns to 9% of the total body surface area due to cutaneous contact with cresol. This was associated with acute oliguric kidney injury requiring haemodialysis. In contrast to previous reports of cresol ingestion, the patient did not have evidence of hepatic dysfunction, possibly due to a low cresol concentration in the portal vein and liver. Renal histopathology showed regional accentuated tubular necrosis and disruption of the tubular basement membrane. Renal toxicity was thought to be due to direct tubular toxicity and impaired renal blood flow.