October 2011-Robert J. McDonald, MD, published in STROKE important results from a study intended to state the prevalence, type, and risk factors connected with intracranial hemorrhage (ICH) in patients who underwent carotid endarterectomy (CEA) or angioplasty and carotid artery stenting (CAS) within the National Inpatient Sample (NIS) From the 2001 to 2008 NIS, the investigators extracted data about postoperative cases of ICH after CEA or CAS. Hospital characteristics, clinical presentation (asymptomatic vs symptomatic), discharge status, in-hospital mortality, demographics were attentively taken into consideration. Multivariate regression was used to find out the impact of revascularization procedure type and symptom status on adverse outcomes, including ICH, in-hospital mortality and unfavorable discharge status.
The investigators specified that 215,012 CEA and 13,884 CAS procedures were performed among 57,663,486 NIS hospital admissions.
Symptomatic presentations represented the minority of CEA (n = 10,049; 5%) and CAS cases (n = 1,251; 10%). ICH occurred significantly more frequently after CAS than after CEA in both symptomatic (4.4% vs 0.8%; P < .0001) and asymptomatic patients(0.5% vs 0.06%; P < .0001). Multivariate regression suggested that symptomatic presentations (vs asymptomatic) and CAS procedures (vs CEA) were both independently predictive of six- to seven-fold increases in the frequency of postoperative ICH and ICH was independently predictive of a 30-fold increased risk of mortality before discharge. In conclusion the study highlighted that CAS procedures are associated with adverse outcomes, including ICH, in-hospital death and unfavorable discharges particularly among symptomatic presentations.

September 2011-In the Journal of the American College of Cardiology, David J. Cohen, MD, published results from a study comparing health-related quality-of-life (HRQOL) outcomes in patients treated with carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in CREST (the Carotid Revascularization Endarterectomy Versus Stenting Trial).Although CREST, the largest randomized trial of carotid revascularization , highlighted no significant difference in the primary composite endpoint yet rates of stroke and myocardial infarction (MI) differed between CAS and CEA. In this substudy, HRQOL was compared among patients enrolled in CREST to help individualized clinical decision making and exploratory analyses were made to evaluate the association between periprocedural complications and HRQOL. The investigators measured HRQOL at baseline, 2 weeks, 1 month, and 1 year after treatment among 2,502 patients who were randomly assigned to either CAS or CEA in the CREST study. They assessed HRQOL using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and six disease-specific scales designed to study HRQOL in patients undergoing carotid revascularization. It was found that at 2 weeks and 1 month, CAS patients had better outcomes for several components of the SF-36.
On the disease-specific scales, CAS patients reported less difficulty with driving, eating/swallowing, neck pain and headaches ( P < .05) but more difficulty with walking and leg pain (all P < .05). However, at 1 year, there were no differences in any of the HRQOL measures between CAS and CEA.
In the exploratory analyses, periprocedural stroke was associated with poorer 1-year HRQOL across all SF-36 components whereas periprocedural MI or cranial nerve palsy were not. The investigators concluded that among patients undergoing carotid revascularization, CAS is associated with better HRQOL during the early recovery period as compared with CEA-particularly with regard to physical limitations and pain-but these differences diminish over time and are no longer evident after 1 year.
Although CAS and CEA are associated with similar overall HRQOL at 1 year, specific analyses confirm that stroke has an impact on HRQOL greater than MI.

May 2011 - The ExoSeal vascular closure device, that provides a safe and precise extravascular arterial closure, got the approval of the US Food and Drug Administration (FDA) to be used in the United States.
Cordis Corporation (Bridgewater, NJ) made this announcement and specified that the ExoSeal , available in European, Asian and Latin-American markets since 2010, will be commercially promoted in the United States in June.
Cordis Company underlined that the safety and efficacy of the ExoSeal were assessed in the United States thanks to the ECLIPSE trial which compared the device with manual compression (MC) with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures.
The trial tested the time to hemostasis, the time to ambulation, and the 30-day combined rate of access site-related complications.
The ECLIPSE trial results showed that the ExoSeal technological developments support the clinical safety of the closure procedure and that extravascular plug placement is associated with no embolization, infection, or other major adverse events, comparable to MC, even though there is significantly shorter time to ambulation for ExoSeal.
The femoral artery puncture site is closed with minimal or no inflammation thanks to a bioabsorbable polyglycolic acid (PGA) plug that is completely reabsorbed within 60 / 90 days. PGA is a non-collagen plug material that is metabolized to carbon dioxide and water.
The use of the device is facilitated by a system of deployment through the existing procedural sheath and no sheath exchange is required during the procedure.
Deployment of the device is guided by visual indicators and patient's comfort during deployment is ensured because of little tugging and pulling.
A proper extravascular plug placement is promoted by the lockout system.

May 2011 - Cordis Corporation (Bridgewater, NJ) announced the launch in Europe of Radial Solutions, a complete portfolio for transradial interventions, including the RadialSource transradial access kit.
RadialSource transradial sheaths provide non-traumatic and smooth access to the radial artery during diagnostic and interventional procedures.
Cordis underlined that the Radial Solutions portfolio includes Cordis' guiding and diagnostic catheters with new specific radial shapes, a transradial sheath introducer, guidewires, and professional education training.
The RadialSource transradial sheath combines a new tapering design and a lubricious coating to facilitate atraumatic entry, to ensure stability during the procedure and to ease removal.
Kits are available with a bare-metal spring mini guidewire or a polymer-coated mini guidewire.
The RIVAL study results comparing radial access and femoral access for coronary angiography and intervention, were presented at the American College of Cardiology's 60th annual scientific session and published in The Lancet.
The RIVAL investigators found that radial access led to reduced rates of vascular complications while maintaining similar angioplasty success rates as femoral access.

May 2011-Abbott Vascular (Santa Clara, CA) announced that the US Food and Drug Administration (FDA) approved the use of RX Acculink carotid stent system, previously indicated only for patients at high risk for adverse surgical events, to be expanded to the endovascular treatment of patients with carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA).
Abbott Company said that this expanded indication was supported by the results of the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial), the largest prospective study comparing carotid artery stenting (CAS) to CEA.

March 2011 - An investigation was carried on by Robert W. Yeh, MD to determine if the postmarketing surveillance (PMS) studies mandated by the US Food and Drug Administration for approved carotid artery stenting (CAS) systems are representative of routine clinical practice.
The investigators compared patient and procedural characteristics, in-hospital outcomes, and subsequent all-cause mortality after CAS in PMS study participants and nonparticipants within the National Cardiovascular Database Registry–Carotid Artery Revascularization and Endarterectomy Registry.
Results stated that participants in PMS studies for CAS have different clinical and procedural characteristics and lower mortality compared with nonparticipants.
Compared with nonparticipants, participants in PMS studies showed to have lower rates of symptomatic carotid artery disease within the preceding 6 months, previous stroke, and acute evolving stroke at baseline. The PMS study participants had lower unadjusted rates of combined in-hospital death, stroke, or myocardial infarction (2.3% vs 4.1%; P <.001), driven by lower rates of stroke (1.7% vs 2.7%; P = .005) and death (0.3% vs 1.4%; P < .001). Differences in survival persisted after propensity score adjustment (odds ratio, 0.44; 95% confidence interval, 0.21 to 0.95; P = .04 for in-hospital mortality; and hazard ratio, 0.80; 95% confidence interval, 0.66 to 0.97; P = .02 for 2-year mortality). Baseline differences in neurological history explained the largest proportion of the difference in outcomes between groups.

September 2010-Boston Scientific Corporation (Natick, MA, USA) announced that patient enrollment in the European ASTI clinical postmarket registry has started.
ASTI is designed to evaluate the company's Adapt carotid stent and monorail delivery system in combination with the FilterWire EZ embolic protection system for the treatment of carotid artery disease.
ASTI is a prospective registry studying clinical outcomes in patients undergoing carotid intervention with the Adapt carotid stent in 10 centers in Europe.
Its primary endpoint is the rate of major adverse events ( major stroke, minor stroke, death, and myocardial infarction) at 30 days.
Secondary endpoints include the rate of ipsilateral stroke, target lesion revascularization, and in-stent restenosis.
The Adapt carotid stent, that isn't available for sale in the USA at the moment, features thin struts and an innovative stent design that enhances flexibility in the carotid artery.
The device incorporates a self-expanding, rolled nitinol sheet that adapts to varying carotid anatomies.
This second-generation carotid stent provides better visibility and its closed-cell geometry is fit for more consistent lesion coverage.

September 2010 In Circulation Sripal Bangalore published findings from the REACH (Reduction of Atherothrombosis for Continued Health) registry comparing the relative efficacy of carotid endartectomy (CEA) and carotid artery stenting (CAS) in preventing late events.
The REACH investigators studied a cohort of patients with a history of carotid artery revascularization and concluded affirming that CAS is comparable to CEA for late outcomes.
More than 68,000 outpatients of about 45 years of age with established atherothrombotic disease or three risk factors for atherothrombosis were recruited.
In addition patients who had undergone CAS or CEA were chosen and followed up for the prospective occurrence of cardiovascular events.
So a cohort of patients in whom all baseline covariates would be well balanced was attentively assembled.
The primary outcome was defined as death or stroke at 2-year follow-up.
The secondary outcome was stroke or transient ischemic attack. The tertiary outcome was a composite of death, myocardial infarction, or stroke and the individual outcomes.
Of the 68,236 patients with atherothrombotic disease or risk for atherothrombosis, 3,412 patients (5%) had a history of carotid artery revascularization (70% asymptomatic carotid stenosis): 1,025 (30%) with CAS and 2,387 (70%) with CEA.
Propensity score analyses matched 836 CAS patients with 836 CEA patients. At the end of a 2 year follow-up, in the propensity score-matched cohort, CAS was associated with a risk similar to CEA for the primary (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.57-1.26), secondary (HR, 1.2; 95% CI, 0.73-1.96), and tertiary (HR, 0.72; 95% CI, 0.51-1.01) composite outcome, death (HR, 0.63; 95% CI, 0.4-1), and stroke (HR, 1.48; 95% CI, 0.79-2.8).

September 2010-A preplanned meta-analysis of individual patient data was published to compare short-term outcomes after CAS versus CEA for symptomatic carotid stenosis.
The investigators concluded that CAS might be as safe as CEA in younger patients (age < 70 years) but should be avoided in older patients (age >= 70 years) with symptomatic carotid stenosis.
This pre-planned meta-analysis was conducted from three randomized controlled trials:
EVA-3S (Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis), SPACE (Stent-Protected Angioplasty Versus Carotid Endarterectomy), and ICSS (International Carotid Stenting Study).
According to the investigators results from these three trials have shown a higher short-term risk of stroke associated with CAS than with CEA for treating symptomatic carotid stenosis.
Data from all 3,433 patients with symptomatic carotid stenosis who were randomly assigned to EVA-3S, SPACE, and ICSS were analyzed with fixed-effect binomial regression models adjusted for the source trial.
The primary outcome event was any stroke or death.
The intention-to-treat (ITT) analysis included all patients and outcome events occurring between randomization and 120 days thereafter.
The per-protocol (PP) analysis was restricted to patients receiving the allocated treatment and events occurring within 30 days after treatment.
In the first 120 days after randomization (ITT analysis), any stroke or death occurred significantly more often in the CAS group (153 of 1,725) than in the CEA group (99 of 1,708) (8.9% vs 5.8%; risk ratio [RR], 1.53, [95% confidence interval [CI], 1.2-1.95]; P = .0006; absolute risk difference, 3.2 [1.4-4.9]).
Only age significantly modified the treatment effect:
in patients younger than 70 years (median age), the estimated 120-day risk of stroke or death was 5.8% in the CAS group (50 of 869 patients) and 5.7% in the CEA group (48 of 843 patients) (RR, 1 [0.68-1.47]).
In patients 70 years or older, the estimated risk with CAS (103 of 856 patients) was twice that with CEA (51 of 865 patients) (12% vs 5.9%; RR, 2.04 [1.48-2.82]; interaction P = .0053, P = .0014 for trend).
In the PP analysis, risk estimates of stroke or death within 30 days of treatment among patients younger than 70 years were 5.1% (43 of 851 patients) in the CAS group and 4.5% (37 of 821 patients) in the CEA group (RR, 1.11 [0.73-1.71).
In patients 70 years or older, the estimates were 10.5% (87 of 828 patients) and 4.4% (36 of 824), respectively (RR, 2.41 [1.65-3.51]; categorical interaction, P = .0078; trend interaction, P = .0013).

May 2010-CORDIS ExoSeal vascular closure device, that received CE Mark approval, will be launched in the European market in June.
The ExoSeal incorporates a polyglycolic acid (PGA) plug, two visual indicators to control the device and lockout features to reduce the risk of complications.
The bioabsorbable PGA plug, that is completely reabsorbed in 60 to 90 days, is designed to close the femoral artery puncture site with minimal or no inflammation.
PGA is a noncollagen plug material that is metabolized into carbon dioxide and water.
A system of deployment through the existing procedural sheath allows for quick and easy use and minimizes the need for sheath exchange during the procedure.
In addition two visual indicators help the correct deployment of the device. ExoSeal's lockout system ensures that only extravascular plug placement can occur.
Two nonrandomized studies held in Mexico and Germany assessed the safety and effectiveness of the device.
In the United States, the 6-F ExoSeal was compared to manual compression with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures.
The trials tested the time to hemostasis, the time to ambulation, and the 30-day combined rate of access site-related complications.
The results showed that there were no major adverse events, vascular repair, access site-related bleeding requiring transfusion, access site-related infection requiring treatment, new ipsilateral lower extremity ischemia, or surgery for access site-related nerve injury.
In addition the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis) trial demonstrated that ExoSeal plug placement was associated with no embolization, infection, or other major adverse events comparable to manual compression despite the significantly shorter time to ambulation for ExoSeal.

May 2010-The Journal of the American College of Cardiology: Cardiovascular Interventions published a study comparing health-related quality of life in patients undergoing artery stenting (CAS) versus surgical endarterectomy (CEA) from the SAPPHIRE (Stenting and Angioplasty with protection in patients at high risk for Endarterectomy)
The SAPPHIRE trial randomized 334 high-risk patients with carotid stenosis to CAS versus CEA.
Health status assessments were obtained at baseline, 2 weeks, and 1, 6, and 12 months after revascularization.
Generic measures included the Short-Form-36 (0-100 scale), general health rating, and EuroQol-5D. In addition, the investigators used six disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain.
According to the investigators, in patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the Short-Form-36 role physical scale (mean difference, 9; 95% confidence interval, 0.9-17.1; P = .031), but these differences had resolved by 1-month follow-up.
For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month.
From these findings, the investigators concluded that among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA.
These differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.

May 2010-Abbott Vascular (Santa Clara, CA, USA) announced that on the basis of the data achieved from the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study, which used the Acculink carotid stent system and Accunet embolic protection system, an expanded indication from the FDA will be asked for the Acculink carotid stent system as a treatment option for patients at standard surgical risk.
As all carotid stent systems in the United States are currently indicated only for high-surgical-risk patients, Abbott stated that also coverage from the Centers for Medicare & Medicaid Services for standard-risk patients will be requested after submitting the CREST data to the FDA.
The CREST results published in the New England Journal of Medicine demonstrated that carotid artery stenting (CAS) and carotid endarterectomy (CEA) had initial safety and longer-term outcomes for symptomatic and asymptomatic patients.
Also adverse event rates such as death,stroke and myocardial infarction were similar for both therapies.
Abbott Vascular said that CREST results were consistent with long-standing American Heart Association guidelines for outcomes in patients with severe carotid stenosis.
These guidelines underline that rates of death and stroke for CEA within 30 days of the procedure should be < 3% for asymptomatic patients and < 6% for symptomatic patients.
The company also stressed the fact that the rate of cranial nerve palsy during the periprocedural period was 4.7% for the CEA group versus 0.3% for the CAS group (representing crossover stenting patients who also underwent the surgical procedure).

May 2010 - At the 33rd annual scientific sessions of SCAI (the Society for Cardiovascular Angiography and Interventions) results from the ARMOUR study of the Mo.Ma protection device (Invatec) were presented.
When the Mo.Ma protection device is placed upstream of a cholesterol blockage in the carotid arteries, it lowers of approximately 75% the 1-month risk of myocardial infarction, stroke, or death.
In 25 USA and Europe medical centers 225 high-surgical risk patients were recruited to evaluate the safety and effectiveness of the Mo.Ma protection device .
In 93% of patients the procedure was successful without MACCE (major adverse cardiovascular or cerebrovascular events) including myocardial infarction, stroke, or death.
Within 30 days of stenting, the combined MACCE rate was 2.7%, whereas a 13% MACCE rate was predicted on the basis of experience with filter protection devices.
The major stroke rate was < 1%.
In addition, patients who suffered from stroke-like symptoms at the time of the procedure had no higher MACCE rate than the overall group, whereas the MACCE rate usually doubles when symptomatic patients are treated with filter protection devices.

March 2010-Catheterization and Cardiovascular Interventions published findings from a study by Arthur Grant MD, of the safety and efficacy of carotid artery stenting (CAS) in the very elderly.
The study deals with the importance of CAS as an alternative to carotid endarterectomy in patients at high risk for surgical complications like the very elderly (aged >/= 80 years). However, there is concern that the very elderly are at increased risk both for carotid surgery and CAS complications.
In fact a stroke and death rate of 12% was reported in very elderly patients during the roll-in phase of CREST (Carotid Revascularization Endarterectomy Versus Stent Trial).
The study investigators reported that between 1994 and 2008, a consecutive series of 418 CAS patients (>/= 80 years of age) were treated at four high-volume centers with extensive CAS experience.
Independent neurologic assessment was performed after CAS procedures.
Thirty-day follow-up information was available for 389 patients. Most patients were men (63.2%), and the target lesion carotid stenosis was asymptomatic in two-thirds of patients (68.2%).
The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%).
One-third (30.1%) were diabetic, and more than half (56.5%) were current or former smokers.
Embolic protection devices (EPDs) were used in 78.7% of cases, with the unavailability of EPDs at the time of CAS being the most common reason for not using them. The overall 30-day incidence of stroke and death was 2.8% (11/389).
The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389).
The study final conclusions were that this large series of CAS with independent neurologic assessment is a convincing evidence that the very elderly can safely undergo CAS with stroke and death rates comparable to younger patients.
But these excellent results can be reached only after a careful patient selection and having CAS performed by skilful and experienced operators.

March 2010-The Society for Vascular Surgery (SVS) published a comment on the recently reported results of CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) and ICSS (International Carotid Stenting Study) comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS) and supported the continued use of CEA over CAS for treating carotid artery disease.
SVS said that several points of the studies deserve to be incorporated into the practice of vascular surgeons but the differing results of the studies make extremely important the physician's careful evaluation of each patient.
According to the SVS, there are some important similarities and differences between these two trials.
Both CREST and ICSS demonstrated a great improvement in the results of CEA over previously reported randomized trials.
The stroke and death rate for symptomatic patients undergoing CEA in CREST was almost half of what was reported in the previous National Institutes of Health trial (NASCET - North American Symptomatic Carotid Endarterectomy Trial) and in ICSS the rate was almost half of what was reported in the earlier European Carotid Surgery trial.
This matches with the excellent results of CEA as reported from many regional and national studies and registries, the National Surgical Quality Improvement Program included.
ICSS stated that endarterectomy, having fewer complications than stenting because strokes and heart attacks occurred less frequently, was the treatment to prefer.
CREST showed that the two procedures were equivalent when all complications (stroke, heart attack, and death) were measured together.
The SVS comment on CREST and ICSS studies wants to emphasize its belief that the primary and most important aim of CEA or CAS is to prevent stroke that may frequently occur after stenting and after endarterectomy but appearing to be minor and little affecting the quality of life.

March 1, 2010-The Society for Cardiovascular Angiography and Interventions announced that the multicenter EPIC (FiberNet Embolic Protection System [EPS] in Carotid Artery Stenting [CAS] Trial) study found that the FiberNet EPS (Lumen Biomedical, Inc., Maple Grove, MN) had a 97.5% success rate when used in patients undergoing CAS.
The EPIC investigators led by Subbarao Myla, MD, evaluated the safety and efficacy of the FiberNet EPS for embolic protection during CAS.
The study was planned to demonstrate that the 30-day major adverse event rate of all death, stroke, and myocardial infarction is significantly less than the 8.3% reported by the ARCHER 3 results published by William A. Gray, MD, et al in the Journal of Vascular Surgery.
The EPIC trial enrolled 237 patients with a mean age of 74 years.
Study participants were 64% men and 20% had symptomatic carotid artery disease (CAD).
Results indicate the combined major adverse event rate at 30 days after carotid endarterectomy for all death, stroke, and heart attack was 3%.
Dr. Myla affirmed that such a rate is encouraging and that the FiberNet EPS, when used with commercially available stents, produces low stroke rates after CAS in high-surgical risk patients with CAD.
Describing the EPIC investigators' experience with the FiberNet device, Dr. Myla said that the low crossing profile and integration of a primary guidewire shortened procedure time and facilitated lesion crossing and filter placement, especially in the presence of tortuous anatomy.
The 0.014-inch guidewire tip demonstrated good torque response, and the guidewire provided excellent support.
FiberNet device was ideal for procedures not requiring a stiff delivery catheter.

January 2010 - MAVERIC (Medtronic AVE Self-Expanding Carotid Stent System With Distal Protection) I and II trials evaluating the safety and feasibility of this system among patients at high risk for surgical endarterectomy have been studied and analyzed by Randall T. Higashida, MD, et al who published their findings in "STROKE".
In MAVERIC I and II were enrolled 99 patients and 399 patients respectively.
Studies went on from June 2001 to October 2004 with a common primary end-point which was the 365-day rate of major adverse events.
Clinical follow-up was done at 30 days, 6 months, and 365 days post-procedure.
In "STROKE" the investigators reported that the 365-day major adverse event rate was 12.5% (defined as death, stroke, or myocardial infarction within 30 days and death, ipsilateral stroke, or myocardial infarction from days 31 to 365).
The incidence of neurological death through 365 days was 1.1%.
The 30-day major adverse event rate was 5.4%.
No notable differences were described in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.
These data demonstrate that treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate.
Also the occurrence of stroke in patients at high risk for carotid endarterectomy appears significantly reduced.

February 2010- At the International Stroke Conference 2010, CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study demonstrated that carotid artery stenting (CAS) and carotid endarterectomy (CEA) show similar long-term safety and efficacy but reveal differences in stroke and heart attack in the weeks after the procedure.
CREST chief investigator Thomas G. Brott, MD, reported that the incidence rates of stroke, heart attack, and death were low in both procedures and safety for patients with and without symptoms was as good as any reported data in other randomized carotid intervention trials.
Dr. Brott said that the patient population (men and women, symptomatic and asymptomatic) with severe carotid artery disease had similar outcomes in the CEA and CAS groups which were the lowest rates ever reported in a randomized clinical trial and that stenting offers a reasonable alternative to carotid artery surgery and is a very useful tool for young patients.

January 2010 - Final agreement to acquire INVATEC (Roncadelle, Italy) and two affiliated companies: FOGAZZI (Brescia, Italy) and KRAUTH Cardio Vascular (Hamburg, Germany) was announced by MEDTRONIC, (Minneapolis, MN).
Invatec works on medical technologies for interventional treatments of cardiovascular diseases whereas Fogazzi provides Invatec with polymer technology and Krauth Cardio Vascular distributes Invatec products in Germany.
MEDTRONIC will pay $350 million to Invatec and in case of Invatec's achievement of specific milestones, $150 million additional payment will follow.
Invatec acquisition enhances Medtronic coronary product offering. In fact Invatec has launched four drug-eluting balloons on the market outside the USA covering the coronaries and lower extremity vessels.
According to Medtronic, Invatec's product line of stents, angioplasty balloons, and accessory products complement therapies and products in Medtronic's CardioVascular business.

January 2010 - MAVERIC (Medtronic AVE Self-Expanding Carotid Stent System With Distal Protection) I and II trials evaluating the safety and feasibility of this system among patients at high risk for surgical endarterectomy have been studied and analyzed by Randall T. Higashida, MD, et al who published their findings in "STROKE".
In MAVERIC I and II were enrolled 99 patients and 399 patients respectively.
Studies went on from June 2001 to October 2004 with a common primary end-point which was the 365-day rate of major adverse events.
Clinical follow-up was done at 30 days, 6 months, and 365 days post-procedure.
In "STROKE" the investigators reported that the 365-day major adverse event rate was 12.5% (defined as death, stroke, or myocardial infarction within 30 days and death, ipsilateral stroke, or myocardial infarction from days 31 to 365).
The incidence of neurological death through 365 days was 1.1%.
The 30-day major adverse event rate was 5.4%.
No notable differences were described in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.
These data demonstrate that treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate.
Also the occurrence of stroke in patients at high risk for carotid endarterectomy appears significantly reduced.