Cardiac Ablation for Type I Atrial Flutter - Boston Scientific

Cardiac Ablation for Type I Atrial Flutter
SVC
Crista
Terminalis
Coronary
Sinus
IVC
Cavotricuspid
Isthmus

BOSTON SCIENTIFIC: Blazer II XP Cardiac Ablation Catheter; EPT-1000XP Controller
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
PMA NUMBER: P020025 DATE OF APPROVAL: 25-Aug-2003
RESULTS* Percentage # of Procedures
Acute Success 94% 250
Six Month Success 96% 151
Major Complications* 8% 250
Pericardial effusion/tamponade 0
Intra-cardiac thrombus 0
TIA 1
CVA 2
Mean ± SD
# of Procedures
Total Saline infused 0 ml 250
Total # of RF Applications/Procedure 11.5 ± 10.6 209
Total Procedure Time 2.1 ± 1.3 hours 234
Total Fluoroscopy Time 28.5 ± 20.2 minutes 232
SUMMARY OF CLINICAL STUDIES*
OBJECTIVE
STUDY DESIGN
The objective of the study was to evaluate the safety and efficacy of the Blazer II XP Cardiac
Ablation Catheter and EPT-1000XP Cardiac Ablation Controller and Accessories for radiofrequency
ablation of sustained or recurrent type I atrial flutter.
The study was a prospective, multi-center, single-arm study using objective performance criteria and
historical control data from the medical literature. Clinical efficacy and safety assessments were performed
at one, three and six months, and at one and two years following the index procedure.
STUDY ENDPOINTS
The primary endpoints for the study were as follows:
Acute Procedural Success: defined as complete bi-directional isthmus block with noninducible
type I atrial flutter with only the use of the Blazer II XP Cardiac Ablation Catheter and EPT-1000XP
Cardiac Ablation Controller and Accessories as assessed at the end of the ablation procedure.
Chronic Effectiveness Success: defined as demonstration of Acute Success and continued
absence of targeted type I atrial flutter for the first six months after the ablation procedure.
Procedural Safety: defined by the absence of serious complications associated with the use of
the investigational device within seven days of the ablation procedure.
PATIENT
ACCOUNTABILITY
Patients enrolled in the study 250
Patients not ablated 0
Patients ablated with EPT-1000 XP Cardiac Ablation System 250
Patients ablated only with EPT-1000 XP Cardiac Ablation System 247
Patients ablated with EPT-1000 XP Cardiac Ablation System
and non-investigational catheter* 5
Patients ablated only with non-investigational catheter 2
*Patients were first ablated with the EPT-1000XP Cardiac Ablation System only. If flutter procedure
could not be completed, then physicians used another catheter to complete the procedure.
These patients were considered acute failures.
STUDY
DEMOGRAPHICS
Male: 205/247 (83%) The average age of the male patients is 60.5 ± 11.1 years.
Female: 42/247 (17%) The average age of the female patients is 63.4 ± 12.4 years.
*For additional information, refer to SSE PMA: P020025 The SSE can be found at: http://www.fda.gov/ohrms/dockets
Enter the product name into the “Search” field.
Note: Data reflected is not from a head-to-head clinical study.

BIOSENSE WEBSTER: NaviStar/Celsius ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
PMA NUMBER: P030031 DATE OF APPROVAL: 24-Nov-2004
RESULTS* Percentage # of Procedures
Acute Success 85% 186
Six Month Success 93% 147
Major Complications* 15.8% 190
Pericardial effusion/tamponade 4
Intra-cardiac thrombus 2
TIA 1
CVA 0
Mean ± SD
# of Procedures
Total Saline infused 999.7 ± 605.5 ml 169
Total # of RF Applications/Procedure 19 ± 16 188
Total Procedure Time 5.7 ± 2.8 hours 190
Total Fluoroscopy Time 50.2 ± 32.4 minutes 189
SUMMARY OF CLINICAL STUDIES*
OBJECTIVE
STUDY DESIGN
STUDY ENDPOINTS
SUBJECT
ACCOUNTABILITY
SUBJECT
DEMOGRAPHICS
The objective of the study was to determine if the NaviStarT ThermoCool catheter, when used in
conjunction with Carto EP/XP Navigation System, Stockert 70 RF Generator and related accessories,
is safe and effective for the treatment of Type I atrial flutter in patients age 18 or older.
The study was a prospective, non-randomized, unblinded, multi-center study conducted at 22
investigational sites (21 sites in US; 1 in Canada).
The endpoints for the study were as follows:
Procedural safety - defined by the absence of serious complication associated with the use of
the investigational device within seven days of the ablation procedure; and Acute procedural
success - defined as complete bi-directional conduction block (BDB) across the isthmus, and
the inability to induce Type I atrial flutter post-procedure.
Long-term freedom from atrial flutter recurrence was not specifically identified as a study endpoint.
Instead, acute procedural success was used as a surrogate endpoint for this parameter.
Long-term (defined as 6 months post-treatment) freedom from atrial flutter recurrence information
was also collected, in order to enable FDA to assess whether the surrogate endpoint
was reasonable.
Subjects enrolled in study 198
Subjects not ablated with the NaviStar ThermoCool catheter 9
Subjects ablated with NaviStar ThermoCool catheter 190
Subjects ablated with NaviStar ThermoCool catheter
and non-investigational catheter* 19
Subjects ablated only with NaviStar ThermoCool catheter 171
*This category includes enrolled subjects who received ablation therapy with the investigational
catheter at the start of the procedure and for whom the investigator then switched to
a non-protocol catheter to complete the procedure. Further, subjects who could not receive
ablation due to investigational device failure are included in this category. These subjects
were considered acute effectiveness failures.
Female: 44/190 (23.2%)
Male: 146/190 (76.8%)
Age Range (years): 18-90 (Mean ± standard deviation 59.8 ± 12.6)
*For additional information, refer to SSE PMA: P030031. The SSE can be found at: http://www.fda.gov/ohrms/dockets
Enter the product name into the “Search” field.
Note: Data reflected is not from a head-to-head clinical study.

BIOSENSE WEBSTER: NaviStar DS Catheter and Celsius DS Diagnostic/Ablation Deflectable Tip Catheters
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
PMA NUMBER: P010068 DATE OF APPROVAL: 27-Sep-2002
RESULTS* Percentage # of Procedures
Acute Success 90% 182
Six Month Success 94% 112
Major Complications* 7% 182
Pericardial effusion/tamponade
not documented
Intra-cardiac thrombus
not documented
Neurological 2
Mean ± SD
# of Procedures
Total Saline infused 0 n/a
Total # of RF Applications/Procedure 24.1 ± 19.7 182
Total Procedure Time 2.7 ± 2.4 hours 178
Total Fluoroscopy Time 31 ± 30 minutes 176
SUMMARY OF CLINICAL STUDIES*
OBJECTIVE
STUDY DESIGN
STUDY ENDPOINTS
SUBJECT
ACCOUNTABILITY
The objective of the study was to determine if the NaviStar DS catheter, when used in conjunction
with the Stockert 70 RF Generator and related accessories, is safe and effective for the treatment
of Type I atrial flutter in patients age 18 or older.
The study was a prospective, non-randomized, unblinded, multi-center study conducted at 16
investigational sites.
The endpoints for the study were as follows:
Procedural safety - defined by the absence of serious complication associated with the use of
the investigational device within seven days of the ablation procedure; and Acute procedural
success - defined as complete bi-directional conduction block (BDB) across the isthmus, and
the inability to induce typical atrial flutter post-procedure.
Long-term freedom from atrial flutter recurrence was not specifically identified as a study endpoint.
Instead, FDA allowed acute procedural success to be used as a surrogate endpoint for
this parameter. Long-term (defined as 6 months post-treatment) freedom from atrial flutter
recurrence information was also collected, in order to enable FDA to assess whether the surrogate
endpoint was reasonable.
Subjects enrolled in study 191
Subjects not ablated 9
Subjects ablated with NaviStar DS catheter 182
Subjects ablated with NaviStar DS catheter
and non-investigational catheter* 15
Patients found to have atypical atrial flutter post ablation** 1
*Patients were first ablated with the NaviStar only. If flutter procedure could not be completed,
then physicians used another catheter to complete procedure. These patients were
considered acute effectiveness failures.
**This patient was considered an acute effectiveness failure.
SUBJECT
DEMOGRAPHICS
Female: 39/182 (21.43%)
Male: 143/182 (78.57%)
Age Range (years): 37-89 (Mean ± standard deviation 64.27 ± 10.20)
*For additional information, refer to SSE PMA: P010068. The SSE can be found at: http://www.fda.gov/ohrms/dockets
Enter the product name into the “Search” field. Note: The EZ Steer Catheter was released under this PMA; substantially
equivalent with a new handle and puller wires. Note: Data reflected is not from a head-to-head clinical study.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. See the appropriate technical manuals
for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential
adverse events. ©2007 Boston Scientific Corporation or its affiliates. All rights reserved. EPT-10559_04/07
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