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Abbott Receives CE Mark for XIENCE Sierra
Abbott announced it received CE Mark for XIENCE Sierra, the newest generation of the company's XIENCE everolimus-eluting coronary stent system. CE Mark allows sale of the device in the European Union and other countries that recognize CE Mark. Advances in this generation of XIENCE include new features that make it easier for cardiologists to successfully complete complex procedures that now account for up to 70 percent of cases.
Abbott has also submitted an application to the U.S. Food and Drug Administration for XIENCE Sierra approval in the United States.
See more about Xience Sierra on Meddevicetracker.
OrbusNeich Presents Top-Line Results from the HARMONEE Trial
OrbusNeich reported new results from the HARMONEE Japan/US Registration Trial in the First Report Investigations session at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in the presentation entitled "HARMONEE: A Randomized Trial of a Bioabsorbable Polymer-Based DES With a Luminal CD34+ Antibody Coating vs a Durable Polymer-Based DES in Patients With Coronary Artery Disease" which demonstrate that the COMBO Dual Therapy Stent (DTS) compares favorably to the market leading option for treating patients (pts) with significant ischemic heart disease.
The Japan-United States of America Harmonized Assessment by Randomized Multicenter Study of OrbusNEich’s Combo StEnt (HARMONEE) is a pivotal (Shonin, Japan) registration study being conducted to demonstrate the effectiveness of the combined endothelial progenitor cell capture and drug-eluting stent (COMBO) compared to the Abbott Vascular Xience stent in patients with ischemic coronary disease and non-ST-elevation acute coronary syndrome.
The HARMONEE study was conducted in 50 hospitals in Japan and the USA, enrolling a total of 572 patients, who were randomized to receive a COMBO stent (287 pts) or a Xience stent (285 pts) in a 1:1 fashion. All patients were followed up at 12 months with quantitative coronary angiography (QCA), including FFR.
The protocol defined primary clinical endpoint of the HARMONEE study was target vessel failure (TVF), a composite of cardiac mortality, myocardial infarction, or ischemic target vessel revascularization within 1 year days post index treatment. Fractional flow reserve (FFR) was used as an objective quantitative indicator for ischemia. OCT assessments were performed after 6 and 12 months in subsets of patients in order to provide mechanistic insights into the healing patterns in both groups, with attention to factors likely to be affected by the EPC capture technology. The mechanistic endpoint was in-vivo EPC "healthy tissue" activity: superiority of COMBO vs EES defined as the % strut-level coverage with >40 micron thickness and negative FFR (OCT).
The results showed that the overall incidence of the primary endpoint target vessel failure (TVF) was lower than the original estimated 9.0%, with 7.0% in the COMBO group vs 4.2% in the Xience group at 12 months, thereby meeting the non-inferiority requirement (P = 0.020).
Kaplan-Meier curves revealed that target vessel revascularization (TVR) events driven by the 1-year protocol re-catheterization were notable in both stent groups, despite the use of fractional flow reserve (FFR) to mitigate such event ‘spikes’. The TVF odds ratio of COMBO versus imputed bare-metal stent (BMS) was 0.673 and did not meet the pre-specified assay sensitivity, but the comparison was underpowered due to the low TVF rates (4.2% vs predicted 9%). COMBO was superior to imputed BMS with respect to angiographic in stent (P<0.001) and in segment late loss (P=0.003) at 12 months.
An independent quantitative coronary arteriography core laboratory reported in stent late loss at 1 year of Combo vs Xience of 0.293 mm vs 0.219 mm and in segment late loss of 0.229 mm vs 0.220 mm respectively. Additionally, the angiographic in stent restenosis of Combo vs Xience was 1.3% vs 2.6% and in segment restenosis was 2.5% vs 3.9%. Optical Coherence Tomography (OCT) at 12 months revealed significantly better healthy tissue strut coverage (thickness >40 micron in patients with normal FFR) with COMBO vs Xience (91.56% vs 74.82%; P<0.001). Also, the qualitative appraisal of the neointima showed more homogeneous tissue with COMBO vs Xience (81.2% vs 68.8%).
The results from HARMONEE build further compelling evidence for COMBO and help to support OrbusNeich’s planned application for approval in Japan and to meet the feasibility trial requirements in the US. Conclusions from the presentation slides were as follows:
See more about the COMBO Stent on Meddevicetracker.
October 31, 2017
Thermo Fisher Signs Development Agreement with Blueprint
Thermo Fisher announced it has expanded the development of its Oncomine Dx Target Test by entering into an agreement with Blueprint Medicines Corporation to develop and commercialize the Oncomine Dx Target Test as a companion diagnostic (CDx) for BLU-667 to identify RET fusions in people with non-small cell lung cancer (NSCLC).
Taken orally, BLU-667 is a potent and selective inhibitor of the kinase RET, including RET fusions and mutations, currently being evaluated by Blueprint Medicines in a Phase I clinical trial for the treatment of patients with RET-driven NSCLC, thyroid cancer and other advanced solid tumors. The CDx will complement efforts to drive enrollment to the trial. Once validation is complete, Thermo Fisher will submit a supplemental premarket approval application to the U.S. Food and Drug Administration (FDA) to expand the clinical claims for its Oncomine Dx Target Test.
Under the terms of the agreement, Thermo Fisher will also retain the rights to commercialize the test globally and will lead all necessary filings to seek clearance from regional regulatory agencies for the test.
The agreement with Blueprint Medicines marks the second CDx development program Thermo Fisher has signed this year to expand the Oncomine Dx Target Test, which received FDA approval in June 2017 and its first positive coverage decision by Regence Blue Cross Blue Shield October 2017. In May 2017, the company announced a similar agreement with Agios Pharmaceuticals to expand the test's indication to include IDH1 mutations in cholangiocarcinoma, a rare form of cancer that affects the human bile duct system with a high unmet medical need.
FDA Issues Update to Warning Letter on Abbott’s ABSORB BVS
The FDA is issuing this update to the March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent.
The FDA was made aware that the manufacturer has stopped global sales of the Absorb GT1 Bioresorbable Vascular Scaffold as of September 14, 2017. The FDA’s recommendations for health care providers outlined in the previous letter remain unchanged. Although health care providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.
While Abbott Vascular has discontinued sales of BVS, the manufacturer will continue to monitor patients currently enrolled in the ABSORB III and ABSORB IV US clinical studies through five years following BVS implantation. Patients enrolled in these studies will be followed through standard practice and care after five years.
The recently available three-year follow-up data from the ABSORB III study continue to show an increased rate of major adverse cardiac events in BVS patients, when compared to patients implanted with the XIENCE stent. Specifically, there was a 13.4 percent rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at three years, compared with 10.4 percent in patients treated with Abbott Vascular's approved metallic drug-eluting stent, the XIENCE stent (p = 0.056).
The risk of BVS-treated patients developing scaffold thrombosis was higher than for patients treated with the XIENCE stent. The ABSORB III study showed a 2.3 percent rate of thrombosis within the BVS scaffold versus 0.7 percent within the XIENCE stent at 3 years (p = 0.01). Most cases of BVS scaffold thrombosis occurred within the first year after BVS implantation, but beyond 1 year, the rate of new thrombosis events remained higher in BVS patients versus XIENCE patients. Long-term follow-up clinical results, including higher rates of major adverse cardiac events and BVS scaffold thrombosis, from the non-US ABSORB II, ABSORB Japan, and ABSORB China studies were generally consistent with the US-based ABSORB III study.
The FDA recommends health care providers:
Updated results from the ABSORB II, ABSORB III, and ABSORB IV Trials were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting on October 31, 2017 in Denver, CO.
See more about the ABSORB BVS on Meddevicetracker.
November 1, 2017
OrbusNeich Presents One-Year Results from the REDUCE Trial
OrbusNeich has reported results from the REDUCE trial in a presentation titled "REDUCE: A Randomized Trial of 3-Month vs 12-Month DAPT After Implantation of a Bioabsorbable Polymer-Based Metallic DES With a Luminal CD34+ Antibody Coating in Patients With ACS" in the Late-Breaking Clinical Trial session at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
REDUCE is a physician-initiated, prospective, multicenter, randomized study, designed to demonstrate non-inferiority of a strategy of short-term (three months) dual antiplatelet therapy (DAPT) as compared to standard 12-month DAPT in patients with ACS treated with a COMBO stent.
The REDUCE study was conducted in 36 hospitals in Europe and Asia, enrolling a total of 1496 ACS patients, who were successfully treated with a COMBO stent. Patients were randomized during index hospitalization (before discharge), in a 1:1 ratio, to either 3-month DAPT or to 12-month DAPT. The protocol defined primary clinical endpoint of the REDUCE study was a composite of all-cause mortality, all myocardial infarction, stent thrombosis, stroke, target vessel revascularization, and moderate or severe bleeding (BARC II, III or V) within 360 days post randomization. Clinical follow-ups were scheduled at 3 months, 6 months and 1 year and will continue out to 2 years post randomization.
The primary endpoint was event of a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization, moderate and major bleeding (BARC II, III or V)).
Secondary endpoints are pre-specified Landmark Analysis of Primary Endpoint from 3 to 12 month and individual components of the composite endpoint
The trial found no difference in the primary endpoint between three and 12 months DAPT (8.2% vs. 8.4%, P noninferiority<0.001; P superiority=0.88) in the intent to treat (ITT) population. The overall incidence of the primary endpoint event (a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization, moderate and major bleeding (BARC II, III or V)) was low at 8.3% in comparison to the original estimate of 12% based on contemporary trials. Furthermore, the results were consistent across all subgroups (age, gender, STEMI vs non-STEMI, geographic region and diabetes) without any significant statistical interaction. A pre-specified landmark analysis of the primary outcome from 3 months (i.e. the intended deviation of antiplatelet therapy between the groups) out to 360 days did not reveal significant differences either.
Among the secondary endpoints, major bleeding rates were similar among the treatment arms (2.5% vs. 3.0%, P=0.54), with non-significantly different rates of overall mortality (1.9% vs. 0.8%, P=0.07), cardiac mortality (1.1% vs. 0.4%, P=0.13), and definite/probable ST (1.2 % vs. 0.4%, P=0.08), although the study was not powered to assess these individual endpoints.
The REDUCE trial is the first study restricted to ACS patients, comparing a short 3-month vs a standard 12-month DAPT. The main finding of the present study: Among ACS patients treated with the COMBO stent, 3-month DAPT is not inferior to 12-month DAPT. This finding is consistent for all pre-specified subgroups. Therefore, a shorter DAPT strategy could be considered, if necessary, even in ACS population. Future larger trials are needed to further investigate and confirm the safety of short-term DAPT regimen in ACS patients in the era of new ADP antagonists and new generation DES.
See more about the COMBO Stent on Meddevicetracker.
Boston Scientific Presents Results from the SENIOR Trial
Results from the SENIOR trial were reported at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in a presentation titled "SENIOR: A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs a BMS With Short DAPT in Patients With Coronary Artery Disease Older Than 75 Years."
The study was published simultaneously in The Lancet.
In this randomised single-blind trial, investigators recruited patients from 1,200 patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y12 inhibitors; contraindication to P2Y12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0.80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked.
The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year.
After the intended duration of DAPT was recorded, 596 were assigned to DES and 604 were assigned to BMS. The stent procedures were successful in 98.1% and 97.6% (P = .561) leading to a complete revascularization at baseline in 85.7% and 86.1% (P = .86) of DES- and BMS-treated patients, respectively. DAPT utilization was similar in both study arms, with approximately half of patients continuing DAPT beyond 1 month, and only 20% of patients (in both groups) continuing DAPT beyond 6 months.
The investigators found that the primary endpoint of all-cause mortality, myocardial infarction, stroke, or ischemia-driven target lesion revascularization occurred in 68 patients (11.6%) in the DES group (n = 584) and in 98 patients (16.4%) in the BMS group (n = 592; relative risk [RR], 0.71; 95% confidence interval [CI], 0.52-0.94; P = .0172). This was mainly driven by ischemia-driven target lesion revascularization, which was reported in 10 patients (1.7%) in the DES group and in 35 patients (5.9%) in the BMS group (RR, 0.29; 95% CI, 0.09–0.49; P = 0.0002). Bleeding complications, evaluated using BARC 2–5, (4.5% vs 5.0%; RR 0.90; 95% CI, 0.51–1.54; P = .68) and stent thrombosis (0.5% vs 1.4%; RR, 0.38; 95% CI, 0–1.48; P = .1315) rates were low in both groups.
PCI with a contemporary thin-strut DES is more effective, and as safe as BMS in elderly patients with CAD, on a short DAPT tailored to their clinical presentation. BMS should no longer be used as a strategy to reduce DAPT duration in elderly patients.
See more about the SYNERGY Bioabsorbable Polymer Stent on Meddevicetracker.
November 2, 2017
Boston Scientific Presents PREVAIL Final Five-Year Results
Boston Scientific announced that it presented final five-year outcomes data from the PREVAIL study of the WATCHMAN Left Atrial Appendage Closure (LAAC) Device during a late-breaking clinical trial session in a presentation titled "PREVAIL: 5-Year Outcomes From a Randomized Trial of Left Atrial Appendage Closure vs Medical Therapy in Patients With Nonvalvular Atrial Fibrillation" at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting on November 2, 2017 in Denver, CO. The study was also subsequently published in the Journal of the American College of Cardiology.
Data from this study were last seen in October 2016.
In the PREVAIL and PROTECT-AF randomized clinical trials, LAAC with the WATCHMAN device was compared to warfarin for stroke prevention in high-risk patients with non-valvular AF. Upon completion of five-year follow up in both trials, study authors conducted a meta-analysis combining all data from the 1,114 randomized patients for a total of 4,343 patient-years.
PREVAIL efficacy endpoints were never designed to be analyzed without the informative prior from PROTECT AF.
The comprehensive analysis confirmed a 55% reduction in disabling or fatal stroke, largely driven by an 80% statistically significant reduction in hemorrhagic stroke. Further, the combined data demonstrated a 52% decrease in non-procedure related major bleeding and 27% reduction in all-cause mortality when compared to long-term warfarin therapy. In addition to stroke prevention comparable to warfarin, the analysis concluded the WATCHMAN device also effectively reduced non-procedure related major bleeding, disabling or fatal stroke, and mortality.
PREVAIL 5 year follow-up demonstrates:
Meta-Analysis of PROTECT AF and PREVAIL with 5 year follow-up demonstrates:
Long term 5-year outcomes of 2 RCTs demonstrate LAAC with the Watchman device provides stroke prevention in NVAF patients to a similar degree as oral anticoagulation. By minimizing major bleeding, particularly hemorrhagic stroke, LAAC results in less disability or death than warfarin. For patients who are poor candidates for long-term oral anticoagulation, left atrial appendage closure is a reasonable strategy for stroke prophylaxis.
See more about WATCHMAN on Meddevicetracker.
ReShape Lifesciences Presents New Data Using ReShape Duo
ReShape Lifesciences presented clinical results from experience in a large multicenter bariatric practice in an abstract titled "342 patients treated at a multicenter bariatric practice" at ObesityWeek 2017.
Following appropriate workup, the IDB was placed endoscopically in an outpatient setting. Patients were scheduled for monthly follow up visits. The balloon was scheduled for endoscopic removal at 6 months. All subjects successfully implanted with the IDB were analyzed for baseline demographics, available weight loss data and safety profile.
Implanted subjects (n=342) were 76% female with the following mean baseline values: age 45 (range 18-72), weight 231 lbs (range 152-450) and BMI 37.5 (range 27.8-65.7). The mean treatment duration for retrieved patients was 166 days (range 3-246) with 276 IDBs retrieved and 66 still implanted. All attempted implantations were successful without complications. Mean weight loss for 240 subjects with 120 days or more of treatment was 24.3 lbs (-8.5, 93), 10.5% of initial body weight (-3.2, 44.5%) and 36.2% of excess body weight (-14, 171%). 81% of patients lost ≥ 5% initial body weight and 49% more than 10% of initial body weight.
For the 300 subjects with at least one weight value, last observation carried forward weight loss values were 23.0 lbs, 10.0% of initial weight and 34.2% of excess weight. Multivariable analysis demonstrated that greater weight loss was associated with older patients (p=0.004), longer periods of IDB treatment (p=0.02) and larger numbers of in-person and virtual follow-up visits (p=0.001). Greater fill volume was also associated with greater weight loss (p=0.07). Seven of 276 retrieved patients (2.5%) had gastric ulcer and all resolved with PPI treatment. Twenty-two of 342 (6.4%) were retrieved before 120 days due to intolerance; these patients had an average weight loss at retrieval of 7.7% of initial body weight. Seven of 342 (2.0%) had balloon deflation; two of these were dual balloon deflations with uneventful rectal passage. Three patients had gastric outlet obstruction requiring retrieval; one of these patients had gastric perforation requiring operative repair. Three patients had pancreatitis requiring hospitalization for resolution; two IDB’s were retrieved and one patient refused retrieval.
The ReShape IDB is a safe and effective endoscopic intervention for weight loss in appropriate patients. 49% of the assessed patients lost at least 10% of initial body weight. Gastric ulceration, deflations, pancreatitis and early retrievals for intolerance occur infrequently and have no long term sequelae when promptly treated.
See more about the ReShape Duo on Meddevicetracker.
November 3, 2017
Paragon 28 Launches Hook Plating System
Paragon 28 announced the U.S. launch of the Hook Plates to the Gorilla Ankle Fracture Plating System. The Gorilla Ankle Fracture Plating System now offers surgeons 52 total plates in ten families. The Hook Plates are offered across three families and provide surgeons eight unique options to address fractures of the tibia and fibula with a hook plate design.
The Paragon 28 Gorilla Ankle Fracture Plating System Hook Plates are 1.5mm thick and have proximal and distal taper to assist in percutaneous insertion. All plates have chamfered edges to minimize soft tissue irritation, and all plates accept 2.7, 3.5, and 4.2 mm locking and non-locking polyaxial screws.
Paragon 28 Gorilla Ankle Plating System – Hook Plates:
Case Specific Instrumentation:
See more about the Gorilla Plating System on Meddevicetracker.
Tandem Diabetes Care Presents New Data Featuring t:slim X2
Tandem Diabetes Care presented results from a Human Factors study conducted to validate the safety of the user interface of a predictive low glucose suspend (PLGS) feature as part of the t:slim X2 Insulin Pump. The data were presented during a poster session at the 2017 Diabetes Technology Meeting (DTM).
The study included users ages 6 and up (N=53), with and without experience using an insulin pump or continuous glucose monitoring (CGM). The study was conducted at four independent research centers in the United States. Training consisted of live one-hour sessions on the t:slim X2 Pump and the Dexcom G5 Mobile CGM System with a break in between. These were waived for current Tandem and Dexcom users, or were shortened for those with previous pump and/or CGM experience. Participants then took a 45-minute computer-based training module on the PLGS feature.
Following a one-hour break, they were asked to complete 10 critical tasks on the device in a simulated environment in order to uncover and identify errors and difficulties. Parents were permitted to help children. Interactions were observed and scored by a researcher seated in a separate observation room. Successful performance required completion of the task without any observed errors or assistance from the study moderator. Pass/fail scoring was completed according to pre-set criteria.
The study demonstrated a 99 percent success rate among study participants who performed a series of critical tasks using the PLGS system after initial training. Out of 530 tasks performed, only seven task failures were observed, none of which were related to safety.
Meddevicetracker: medical device intelligence and forecasts
What were the outcomes of critical catalysts featured in Meddevicetracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.
Topics Drug approval
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