vesiflo intro presentation - media templeqvw6-6ys8.accessdomain.com/vesiflo/wp-content/... ·...
TRANSCRIPT
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Clinical Background and Urology Practice Overview
Active Urologic
Practice
The inFlow™
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Female Urinary Prosthesis
Activator remote control
inFlow device
Internal valve-pump
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Indication for Use
The inFlow Intraurethral Valve-Pump
and Activator is a replaceable
urinary prosthesis intended for use
in adult females who have
incomplete bladder emptying due to
impaired detrusor contractility of
neurologic origin
Device must be replaced every 29 days
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A Population in Acute Need
Although very commonly used, urinary catheters cause multiple
problems, particularly with chronic use
Infection, encrustation and low quality of life
These problems are amplified for women with IDC
Since IDC is generally incurable, most now use catheters on a life-long basis
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You Can Provide a Better Alternative
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The inFlow urinary prosthesis for women with IDC
An active bladder drainage device that replaces passive urinary catheters
They cannot generate bladder pressure,
so the inFlow pumps the urine out
Close-up of Internal Valve-Pump Mechanism
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Device Use
inFlow device is inserted
into urethra and remains
in place for 29 days
Allows dignified urination
on demand
Pressing Activator button
engages internal pump
Pumps urine out of bladder
at a normal flow rate
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Results of Pivotal Trial
Primary and Secondary Clinical Endpoints
Post-Void Residual: 98% of subjects reported no clinically significant PVR
Quality of Life: 50% better than CIC
• 80% better in an independently conducted long-term study (Lynch et al)
Safety Profile
Infection: Lower UTI rate than for CIC (or any method of bladder drainage)
• FDA: “It is noteworthy that the most significant of adverse events – UTI – appears to
occur at a lower rate with the inFlow device as compared to CIC.”
Other Adverse Events: No reports of serious or long-lasting AEs
• Not in seven peer-reviewed clinical studies (n=501) or in years of use outside the U.S.
Encrustation: No encrustation reported
• Per Stickler study, encrustation resistance >8.4x better than for silicone Foley catheter
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Mostly, inFlow Improves Lives…
Eliminates tubes, bags
Normalizes toileting
Restores personal dignity
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Adding to the Armamentarium
CIC can be a good option, but many cannot or will not self-catheterize
IDC typically results from disabling conditions such as MS, stroke, SCI
Many women, elderly particularly, are reluctant to repeatedly touch genital area
These women would generally be relegated to Foleys or suprapubics,
but many can use the inFlow
The inFlow will provide them with safety and effectiveness comparable to CIC
The inFlow also improves quality of life for most CIC users
50-80% improvement over CIC in clinical studies
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Physician Interaction and Coding
Summary of physician services
Visit 1: Cysto and urethral sizing
Visit 2: Device insertion and patient/caregiver training
Thereafter: Evaluation and prescription every six months, possible
cystoscopic examination at 1-2 years
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Identifying Patients - Medical Justification
Most women with IDC are readily identified via history or bladder scan
Current chronic catheterization
Multiple bladder scans with significant (>100cc) PVR (CPT 51798)
Urodynamics study justified (CPT 51727/51728/51729, 51784 optional)
IDC is technically a UDS finding
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Office Visit 1
Patient with established IDC presents herself for evaluation
Cystourethroscopy is performed (CPT 52000)
Needed to assess condition of urethral sphincter, suitability for urethral inserts
Urethral length is measured with measurement insert and recorded
Needed to determine appropriate size of inFlow device
Patient is discharged
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Office Visit 2 - Device Insertion
Procedure following preparation as for indwelling urinary catheter:
Figure 1
1. Insert device until meatal tab makes contact (Figure 1)
Figure 2
2. Deploy device by depressing Introducer plunger (Figure 2)
Figure 3
3. Flexible silicone “petals” provide fixation at bladder neck (Figure 3)
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Office Visit 2 - New Patient Support
Initial device training
Supervise patient’s first use of device to void
Establish nurse or other point of contact within practice for continued patient
education, post-insertion follow-up, etc.
Post-insertion follow-up
Like most other prosthetic devices, the inFlow can require a period of
accommodation and adjustment to work well for many patients
Proactive calls by nurses are crucial to identify problems, reassure patients
Schedule visits according to patient condition and likelihood of complications
Vesiflo will be offering online training for both physicians and nurses
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Summary
The inFlow may be the best solution to date for an age-old problem:
How to remove urine from the bladder without causing infection
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The inFlow acts as a urinary prosthesis for women with IDC
They cannot generate bladder pressure, so the inFlow pumps the urine out
Normalizes toileting, transforms lives for a population in acute need
Increases practice revenues without adding to overhead
Attracts new patients who need workup that includes cysto and routine office
visits that largely involve RN, other present office staff
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“The inFlow device is truly remarkable in its ability to virtually restore the functional
behavior of the urinary bladder. No other product, drug, or device can accomplish this to
the same degree. The device should be given a high priority consideration for all female
patients having difficulty emptying their bladders.” -R Schmidt, MD, InterStim® Co-Inventor
Thank You