» PIVIT™ CRM is a specialized polypropylene mesh pouch designed to provide a stable environment for the cardiac rhythm implant.
» The mesh contains antibacterial agents, rifampin and minocylin in a bioresorbable coating.
More About PIVIT™ CRM
PACEMAKER AND ICD INFECTION IS A GROWING PROBLEM
Each year more patients are implanted with Pacemakers and ICDs,
and each year the incidence of microbial colonization increases1,2,3,8
The increase in the incidence of infection exceeds the
increase in the rate of implantation.1,3
2.6% 19963
5.3% 20033
Physician concern about PM/ICD infections is reflected
in the increase in peer reviewed articles4
600 articles since 1990
1990- 23 articles regarding PM/ICD Infections
2005- 52 articles regarding PM/ICD Infections
The Insertion pocket is the most
common site of PM/ICD Infection
The generator pocket was identified as the portal of entry in 59% (13 out of 22).6
42% of uninfected patients had positive pocket cultures at time of revision.5
The cost of infection surrounding
a PM or ICD is high
1 out of 10 patients with Cardiac Device Infections
develop Endocarditis.8
“Staphylococcus aureus bacteremia is associated with a high mortality rate despite all important advances and diagnoses and treatments”7
High mortality in patients with infected CRDs.6
ICD infections add $50,000 to medical system expenses.8
The optimal treatment of the infected pacemaker and ICD is complete explantation of all hardware6,8
PREVENTION OF BACTERIAL COLONIZATION AT IMPLANTATION SITE
Pivit™CRM is a mesh pouch which holds a pacemaker or ICD, creating a stable environment surrounding the device and leads after placement. The mesh contains antibacterial agents to help provide protection from microbial colonization of the generator or defibrillator during and immediately after surgical implant.
Releases the antibacterial agents over 7-10 days in vitro
Demonstrated Effectiveness on Common Bacteria Found in Implant Pocket Infections9
Staphlococcus epidermis and aureus, and MRSA growth was inhibited at inoculum levels of 104-108 CFU/cc
With a 10 mm or greater zone of inhibition up to 10 days in 107 CFU/cc inoculum level of Staph E, A and MRSA
Rifampin + Minocyclin have
demonstrated reduced microbial
colonization on surgical implants
An effective antimicrobial combination proven in human clinical trials to lower device-related blook born infections10
Demonstrated on Venous Catheters to significantly
reduce infection (3-6.5 x) and colonization on catheters
(OR 0.46, 95%; CI .31-.69) without adverse events.10,12
And on other products such as Penile Implants,
Hernia Mesh, and Bladder Slings9
Infection rates were reduced from 1.59% to 0.28%
(p=0.0034) in penile implants at 60 days.13
Shown Effective in Pre-Clinical Study14
Four Canines: Four Devices each animal
8 control units: Pacemaker alone
8 test units: Pacemaker in Pivit™ CRM
16 total devices
Insertion pockets inoculated with a 5 x 105 concentration of staphylococcus aureus at implant
Explanted after 14 days
POLYPROPYLENE BASE STRUCTURE - DEMONSTRATED BIOCOMPATIBILITY
Expected Encapsulation Pocket Formation with the Pivit™CRM
Pivit™ CRM
Monofilament polypropylene mesh
coated with bioresorbable coating
containing rifampin and minocycline
Typical PM/ICD Device Healing Tissue Type and Structure
The base material is monofilament polypropylene similar to the most
common suture used in cardiac anastomosis.
Clinical studies have shown monofilament polypropylene does not
cause the intense chronic inflammation and subsequent tissue ingrowth
of a polyester.15,16
In a study of 200 hernia mesh implants, monofilament polypropylene
was shown to have fewer infections than multifilament polyester
(0% vs 16%, p<0.05).16
Device revision with the Pivit™CRM
All Pacemaker/Pivit™CRM combinations were easily removed
during pre-clinical research
Excess leads are placed into and contained by Pivit™ CRM
Device access unhindered: Compliant, supple polypropylene
base material is soft and easy to cut
Blunt dissection can be used to easily expand the perimeter of Pivit™ CRM
INHIBIT MICROBIAL COLONIZATION
Pivit™CRM is a mesh pouch which holds a pacemaker or
ICD, creating a stable environment surrounding the device
and leads after placement. The mesh contains antibacterial
agents to help provide protection from microbial
colonization of the generator or defibrillator during and
immediately after surgical implant.
1 Voigt, Andrew, Alaa Shalaby, Samir Saba. Rising Rates of Cardiac Rhythem Management Device Infections in the US 1996-2003. J Am Coll Cardiol, 2006 48:590-591.
2 Dy Chua Jimmy, Wilkoff Bruce L., Lee Irene, Juratli Nour, Longworth David L., Gordon Steven. Diagnosis and Management of Infections Involving ImplantableElectrophysiologic Cardiac Devices. Annals of Internal Medicine Vol 133, No. 8, Oct 17, 2000: 604-608.
3 Stiles Steve. ICD, Pacemaker infection rates seem to grow faster than number of implantations. www.theheart.org. May 26, 2000
4 Dy Chua Jimmy, Abdul-karim Ahmad, Mawhorter Steven, Procop Gary W., Tchou Patrick, Niebauer Mark, Saliba Walid, Schweikert Robert, Wilkoff Bruce L..
The Role of Swab and Tissue Culture in the Diagnosis of Implantable Cardiac Device Infection., PACE Vol 28 Dec 2005, pgs 1276-1281.
5 NIH web site: http://www.ncbi.nih.gov
6 Gandelman Glen, Frishman William, Wiese Cristina, Green-Gastwirth Vanessa, Hong Steven, Aronow Wilbert, Horowitz Harold. Intravascular Device Infections –
Epidemiology, Diagnosis, and Management. Cardiology in Review: Vol 15, No. 1 Jan/Feb 2007 pgs 13-23.
7 Wood Shelley. High Rate of pacemaker and ICD infection in patients who develop Staphylococcus aureus infection. TheHeart.org. August 27, 2001 21:50:00.
7 Uslan Daniel Z. Baddour, Larry M.; Cardiac Device Infections: Getting to the Heart of the Matter. Curr Opin Infect Dis 19: 345-348.
9 Data on File at TyRx Pharma.
10 Radd Issam, Darouiche Rabih, Dupuis Jackques, et al. Central Venous Catheters Coated with Minocycline and Rifampin for the Prevention of Catheter-Related
Colonization and Bloodstream Infections. Annals of Internal Medicine. 08/15/97, Vol 127 Issue 4. p 267-274.
11 Shorr Andrew, Humphreys Christopher, Helman Donald L. New Choices for Central Venous Catheters: Potential Financial Complications. CHEST/124/1/July, 2003; pg 275-284.
12 Falagas Matthew E., Fragoulis Konstantinos, Bliziotis Ioannis A., Chatzinikolaou Ioannis. Rifampicin-impregnated central venous catheters: a meta-analysis of randomized
controlled trials. Journal of Antimicrobial Chemotherapy 2007; 59 (3): 359-369.
13 Carson Culley C. III. Efficacy of antibiotic impregnation of inflatable penile prosthesis in decreasing infection in original implants., J. Urol. April 2004; 171:1611-1614
14 Parsonett Victor. Data on File at TyRx Pharma, presented at HRS 2007
15 Parsonnet Victor, Bernstein Alan D., Neglia Donna, Omar Arif. The Usefulness of a Stretch-Polyester Pouch to Encase Implanted Pacemakers and Defibrillators. Pacing
and Clinical Electrophysiology April 1994, 17 (12), 2274-2278.
16 Marois Y, Cadi R., Gourdon J., Gatouraee N., King M.W., Zhang Z., Guidoin R.. Biostability, inflammatory response, and healing characteristics of a fluoropassivated
polyester-knit mesh in the repair of experimental abdominal hernias. Artificial Organs., 2000 July ; 24 (7) : 533-43.
17 Leber G.E., Garb J.L., Alesander A.I., Reed W.P.. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998 April; 133 (4): 378-82.
18 Data on File at TyRx Pharma.
Contraindications: The Pivit™ CRM is NOT indicated for use in the following situations
• Allergy or history of allergy to tetracyclines, rifampin, or polypropylene
• In patients with systemic lupus erythromatosis because minocycline has been reported to aggravate this condition
Use of the Pivit™ CRM in contaminated wounds is not recommended. If used, it should be understood that any infection may adversely affect proper wound healing and integration into the tissue and may result in the removal of the material.
INHIBIT MICROBIAL COLONIZATION