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| MRI safety Status | Labeling does not contain MRI Safety Information |
|---|---|
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) | No |
| Device labeled as "Not made with natural rubber latex" | True |
| For Single-Use | True |
| Prescription Use (Rx) | True |
| Over the Counter (OTC) | No |
| Kit | No |
| Combination Product | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) | No |
| GMDN Preferred Term Name | GMDN Definition |
|---|---|
| Emboli capture guidewire | A sterile, steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to capture any emboli that may result from the procedure. The filter is deployable (expandable) once it has been inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices dedicated to introduction/removal of the guidewire (e.g., deployment/removal sheath, introducer), which are not intended to be used as working channels for other interventional devices. This is a single-use device. |
| Product Code | Product Code Name |
|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture |
| Jan 2017 to Dec 2017 Medicare Hospitalizations | Jan 2013 to Dec 2017 Medicare Hospitalizations | |
|---|---|---|
| Inpatient (For Included Categories & DRGs) | 27 | 145 |
| Surgical (For Included Categories & DRGs) | 27 | 145 |
| Cardiovascular (For Included DRGs) | 27 | 145 |
| CAROTID ARTERY STENT PROCEDURE | 27 | 145 |
| Inpatient All (For Included Categories & DRGs) | Inpatient - Surgical (For Included Categories & DRGs) | |||
|---|---|---|---|---|
| Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | |
| Total Hospitalizations | 27 | 145 | 27 | 145 |
| Total Hospitalizations After Exclusion | 27 | 145 | 27 | 145 |
| Avg. LOS | 3.04 | 3.01 | 3.04 | 3.01 |
| All Cause Readmission Rate (%) | ||||
| Unplanned Readmission Rate (%) | ||||
| ICU Stays | ||||
| Avg. Number of Days in ICU per ICU Stay | ||||
| Total Medicare Payments | $463,674 | $2,664,015 | $463,674 | $2,664,015 |
| Payment per Day | $5,654 | $6,096 | $5,654 | $6,096 |
| Payment per Hospitalization | $17,173 | $18,372 | $17,173 | $18,372 |
| Total Medicare Charges | $2,013,029 | $11,248,656 | $2,013,029 | $11,248,656 |
| Avg. Charges | $74,557 | $77,577 | $74,557 | $77,577 |
| Mortality Rate (%) | ||||
| SNF Discharge Rate (%) | NA | 8.97 | NA | 8.97 |
| Home Discharge Rate (%) | 74.07 | 72.41 | 74.07 | 72.41 |
| Coronary Artery Disease | ||||
| Total Hospitalizations with Coronary Artery Disease | ||||
| Total Hospitalizations After Exclusion with Coronary Artery Disease | ||||
| Avg. LOS with Coronary Artery Disease | ||||
| 30 Day Coronary Artery Disease Readmission Rate (%) | ||||
| 30 Day Readmission Rate with Coronary Artery Disease(%) | ||||
| 30 Day Coronary Artery Disease Unplanned Readmission Rate (%) | ||||
| ICU Stays with Coronary Artery Disease | ||||
| Avg. Number of Days in ICU per ICU Stay with Coronary Artery Disease | ||||
| Medicare Payments with Coronary Artery Disease | ||||
| Payment per Day with Coronary Artery Disease | ||||
| Payment per Hospitalization with Coronary Artery Disease | ||||
| Medicare Charges with Coronary Artery Disease | ||||
| Avg. Charges with Coronary Artery Disease | ||||
| Inpatient Hospital Mortality Rate (%) with Coronary Artery Disease | ||||
| SNF Discharge Rate (%) with Coronary Artery Disease | ||||
| Home Discharge Rate (%) with Coronary Artery Disease | ||||
| Incidence Rate (%) with Coronary Artery Disease | ||||
| Incidence Rate (%) with Coronary Artery Disease after Exclusions | ||||
| ICD Code | ICD Description | Total ICD & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total ICD & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 43310 | Occlusion and stenosis of carotid artery without mention of cerebral infarction | 73 | NA | 50.34 | NA |
| Procedure Code | Procedure Description | Total Procedure Code & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total Procedure Code & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 0061 | 85 | NA | 58.62 | NA | |
| Cardiovascular (For Included DRGs) | Cardiovascular - Surgical (For Included DRGs) | |||
|---|---|---|---|---|
| Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | |
| Total Hospitalizations | 27 | 145 | 27 | 145 |
| Total Hospitalizations After Exclusion | 27 | 145 | 27 | 145 |
| Avg. LOS | 3.04 | 3.01 | 3.04 | 3.01 |
| All Cause Readmission Rate (%) | ||||
| Unplanned Readmission Rate (%) | ||||
| ICU Stays | ||||
| Avg. Number of Days in ICU per ICU Stay | ||||
| Total Medicare Payments | $463,674 | $2,664,015 | $463,674 | $2,664,015 |
| Payment per Day | $5,654 | $6,096 | $5,654 | $6,096 |
| Payment per Hospitalization | $17,173 | $18,372 | $17,173 | $18,372 |
| Total Medicare Charges | $2,013,029 | $11,248,656 | $2,013,029 | $11,248,656 |
| Avg. Charges | $74,557 | $77,577 | $74,557 | $77,577 |
| Mortality Rate (%) | ||||
| SNF Discharge Rate (%) | NA | 8.97 | NA | 8.97 |
| Home Discharge Rate (%) | 74.07 | 72.41 | 74.07 | 72.41 |
| Coronary Artery Disease | ||||
| Total Hospitalizations with Coronary Artery Disease | ||||
| Total Hospitalizations After Exclusion with Coronary Artery Disease | ||||
| Avg. LOS with Coronary Artery Disease | ||||
| 30 Day Coronary Artery Disease Readmission Rate (%) | ||||
| 30 Day Readmission Rate with Coronary Artery Disease(%) | ||||
| 30 Day Coronary Artery Disease Unplanned Readmission Rate (%) | ||||
| ICU Stays with Coronary Artery Disease | ||||
| Avg. Number of Days in ICU per ICU Stay with Coronary Artery Disease | ||||
| Medicare Payments with Coronary Artery Disease | ||||
| Payment per Day with Coronary Artery Disease | ||||
| Payment per Hospitalization with Coronary Artery Disease | ||||
| Medicare Charges with Coronary Artery Disease | ||||
| Avg. Charges with Coronary Artery Disease | ||||
| Inpatient Hospital Mortality Rate (%) with Coronary Artery Disease | ||||
| SNF Discharge Rate (%) with Coronary Artery Disease | ||||
| Home Discharge Rate (%) with Coronary Artery Disease | ||||
| Incidence Rate (%) with Coronary Artery Disease | ||||
| Incidence Rate (%) with Coronary Artery Disease after Exclusions | ||||
| ICD Code | ICD Description | Total ICD & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total ICD & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 43310 | Occlusion and stenosis of carotid artery without mention of cerebral infarction | 73 | NA | 50.34 | NA |
| Procedure Code | Procedure Description | Total Procedure Code & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total Procedure Code & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 0061 | 85 | NA | 58.62 | NA | |
| CAROTID ARTERY STENT PROCEDURE - Cardiovascular | DRG 036 : CAROTID ARTERY STENT PROCEDURE WITHOUT COMPLICATION OR COMORBIDITY/MAJOR COMPLICATION OR COMORBIDITY | DRG 035 : CAROTID ARTERY STENT PROCEDURE WITH COMPLICATION OR COMORBIDITY | DRG 034 : CAROTID ARTERY STENT PROCEDURE WITH MAJOR COMPLICATION OR COMORBIDITY | |||||
|---|---|---|---|---|---|---|---|---|
| DRG Group | CAROTID ARTERY STENT PROCEDURE | CAROTID ARTERY STENT PROCEDURE | CAROTID ARTERY STENT PROCEDURE | CAROTID ARTERY STENT PROCEDURE | ||||
| Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | Jan 2017 to Dec 2017 | Jan 2013 to Dec 2017 | |
| Total Hospitalizations | 27 | 145 | 12 | 75 | NA | 54 | NA | 16 |
| Total Hospitalizations After Exclusion | 27 | 145 | 12 | 75 | NA | 54 | NA | 16 |
| Avg. LOS | 3.04 | 3.01 | 1.25 | 2.12 | NA | 3.19 | NA | 6.63 |
| All Cause Readmission Rate (%) | ||||||||
| Unplanned Readmission Rate (%) | ||||||||
| ICU Stays | ||||||||
| Avg. Number of Days in ICU per ICU Stay | ||||||||
| Total Medicare Payments | $463,674 | $2,664,015 | $158,746 | $1,099,945 | NA | $973,432 | NA | $590,637 |
| Payment per Day | $5,654 | $6,096 | $10,583 | $6,917 | NA | $5,659 | NA | $5,572 |
| Payment per Hospitalization | $17,173 | $18,372 | $13,228 | $14,665 | NA | $18,026 | NA | $36,914 |
| Total Medicare Charges | $2,013,029 | $11,248,656 | $644,806 | $4,685,841 | NA | $4,484,077 | NA | $2,078,738 |
| Avg. Charges | $74,557 | $77,577 | $53,734 | $62,478 | NA | $83,038 | NA | $129,921 |
| Mortality Rate (%) | ||||||||
| SNF Discharge Rate (%) | NA | 8.97 | NA | NA | NA | NA | NA | NA |
| Home Discharge Rate (%) | 74.07 | 72.41 | 100.00 | 81.33 | NA | 74.07 | NA | NA |
| Coronary Artery Disease | ||||||||
| Total Hospitalizations with Coronary Artery Disease | ||||||||
| Total Hospitalizations After Exclusion with Coronary Artery Disease | ||||||||
| Avg. LOS with Coronary Artery Disease | ||||||||
| 30 Day Coronary Artery Disease Readmission Rate (%) | ||||||||
| 30 Day Readmission Rate with Coronary Artery Disease(%) | ||||||||
| 30 Day Coronary Artery Disease Unplanned Readmission Rate (%) | ||||||||
| ICU Stays with Coronary Artery Disease | ||||||||
| Avg. Number of Days in ICU per ICU Stay with Coronary Artery Disease | ||||||||
| Medicare Payments with Coronary Artery Disease | ||||||||
| Payment per Day with Coronary Artery Disease | ||||||||
| Payment per Hospitalization with Coronary Artery Disease | ||||||||
| Medicare Charges with Coronary Artery Disease | ||||||||
| Avg. Charges with Coronary Artery Disease | ||||||||
| Inpatient Hospital Mortality Rate (%) with Coronary Artery Disease | ||||||||
| SNF Discharge Rate (%) with Coronary Artery Disease | ||||||||
| Home Discharge Rate (%) with Coronary Artery Disease | ||||||||
| Incidence Rate (%) with Coronary Artery Disease | ||||||||
| Incidence Rate (%) with Coronary Artery Disease after Exclusions | ||||||||
| ICD Code | ICD Description | Total ICD & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total ICD & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 43310 | Occlusion and stenosis of carotid artery without mention of cerebral infarction | 73 | NA | 50.34 | NA |
| Procedure Code | Procedure Code Description | Total Procedure Code & DRG Hospitalization Volume - Jan 2013 to Dec 2017 | Total Procedure Code & DRG Hospitalization Volume - Jan 2017 to Dec 2017 | % of DRG Volume - Jan 2013 to Dec 2017 | % of DRG Volume - Jan 2017 to Dec 2017 |
|---|---|---|---|---|---|
| 0061 | 85 | NA | 58.62 | NA | |
| Physician Name | Total Hospitalizations - Jan 2013 to Dec 2017 | Total Hospitalizations - Jan 2017 to Dec 2017 |
|---|---|---|
| DR. CARLOS I MENA-HURTADO | 150 | 23 |
| DR. CHARLES CHRISTIAN MATOUK | 38 | NA |
| DR. BRIAN W COYLE | 13 | NA |