https://na-sj04.marketodesigner.com/m?explictHostname=app-sj04.marketo.com#LPTE5875 Phasix ST Mesh












THE DIFFERENCE IS

PUTTING PRECISION
TO WORK


Clinical Study:
Low early hernia recurrence rates with Dr. DeMeester







Low recurrence rates1



Predictable repair strength2,3



Durable repair for crural reinforcement1



No reported mesh-related complications1


Discovery. Diagnostics. Delivery.

Can be accessed on our Customer Learning Portal. The e-learning courses offer detailed and solution focused training to help better understand how to solve for common scenarios.

Experts from around the globe describe the intersection between patient and healthcare worker safety, focusing on techniques to improve both occupational and public health.

Webinar Objectives:

  • Describe the current global impact of bloodborne disease
  • Describe occupational exposure incidents for needlesticks and sharps injuries
  • Define safety as a function of focus for both patient and health worker, to reduce overall bloodborne disease
  • Provide guidance on the importance of prevention programs including use of safer medical devices, immunization/vaccination programs, and safe clinical practices
  • Illustrate an effective pathway for reporting exposure incidents and injuries
  • Define processes for post-exposure medical treatment and prophylaxis
  • Share global experiences from key stakeholders responsible for sharps safety and public health programs around the world

Save Your Seat


Phasix™ ST Mesh

The only bioresorbable mesh with a proven hydrogel barrier for hiatal hernia repair





Demonstration

Watch
Dr. Steven DeMeester demonstrate his
approach to
laparoscopic hiatal
hernia repair with
Phasix™ ST Mesh.

Watch Now


Clinical Data

Access
our compendium
of clinical data to
further understand how
Phasix™ ST Mesh
performs in hiatal
hernia repair.

Download clinical compendium


Education

BD is proud to sponsor HerniaU, a dynamic online resource for hernia repair education events, including live surgeries, case studies, lectures & comprehensive training courses.

Visit HerniaU





Repairs

The open monofilament mesh structure provides early integration and repair strength.3





Remodels

Vascular integration and incorporation continues, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time.3





Restores

As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year.3

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Play

Ibus exped et ape

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Ibus exped et ape

Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas vestibulum tortor quam.

Ibus exped et ape

Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas vestibulum tortor quam.

Let's have a conversation















Rapid tissue incorporation 1



Organized and functional collagen at the repair site1



4x the strength of the native abdominal wall at 24 weeks in preclinical testing1

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Pellentesque habitant morbi

  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada

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Pellentesque habitant morbi

  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada
  • Tristique senectus et netus et malesuada

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Predictable strength for the long run

  • Long-term strength with no permanent material left behind2,3
  • Organized and functional collagen at the repair site3

Placeholder

Predictable strength for the long run

  • Long-term strength with no permanent material left behind2,3
  • Over 2x the strength of other bioresorbable mesh3
  • Predictable resorption time3
  • Minimizes risk of tissue attachment3

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360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation.

360° rotation knob is effectively sized

360° rotation knob is effectively sized

360° rotation knob is effectively sized

More product details

Resources and education

Hospitals and healthcare facilities

BD is a market leader in hospital products that can reduce the incidence of sharps injuries and exposure to bloodborne pathogens. Patient safety has been a focus of BD innovation for years, not only in the United States but also around the world. Working closely with organizations like the International Safety Center (EPINet) is an important part of our efforts to keep patients and workers safe.

Safety syringes and needles >>
Hazardous drug safety >>
Infection prevention >>

Hospitals and healthcare facilities

BD is a market leader in hospital products that can reduce the incidence of sharps injuries and exposure to bloodborne pathogens. Patient safety has been a focus of BD innovation for years, not only in the United States but also around the world. Working closely with organizations like the International Safety Center (EPINet) is an important part of our efforts to keep patients and workers safe.

Safety syringes and needles >>
Hazardous drug safety >>
Infection prevention >>

Combining two market-leading technologies into one product: monofilament bioresorbable Phasix™ Mesh and a clinically-proven Sepra® Technology (ST) hydrogel barrier.

Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas vestibulum tortor quam.

Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas vestibulum tortor quam.

Let's have a conversation



Mesh selection matters


8%

In a study with
Dr. Steven DeMeester,
Phasix™ ST Mesh is associated with an
8% recurrence rate at a median follow-up of
12 months1

42%

Dr. Carlos Galvani
utilized Gore Bio-A®
and reported a 42% recurrence rate at a median follow-up of
24 months4

56%

In a randomized controlled study,
Cook Surgisis® (Biodesign®) is associated with a
56% recurrence rate at a median follow-up of
58 months5



Let's have a conversation

REFERENCES

1. Abdelmoaty WF, Dunst CM, Filicori F, et al. Combination of surgical technique and bioresorbable mesh reinforcement of the crural repair leads to low early hernia recurrence rates with laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 2020;24(7):1477-1481. doi:10.1007/s11605-019-04358-y. 2. Deeken CR, Matthews BD. Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (Poly-4-hydroxybutyrate-Phasix™ Mesh) in a porcine model of hernia repair. ISRN Surg. 2013;2013:238067. Published 2013 May 28. Doi: 10.1155/2013/238067. 3. Data on file. Preclinical results may not correlate to clinical performance. 4. Galvani, C. et al. 2016. Robotic-assisted paraesophageal hernia repair: initial experience at a single institution. J Laparoendosc Adv Surg Tech A. 2016 Apr;26(4):290-5. 5. Watson DI, Thompson SK, Devitt PG, et al. Five year follow-up of a randomized controlled trial of laparoscopic repair of very large hiatus hernia with sutures versus absorbable versus nonabsorbable mesh. Ann Surg. 2020;272(2):241-247. doi:10.1097/SLA.0000000000003734

Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias, including hiatal hernias.

CONTRAINDICTIONS
Because Phasix™ ST Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.


WARNINGS
Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.

Ensure proper orientation; the coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the uncoated mesh side against the bowel. There is a risk for adhesion formation or erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera. (Reference Surface Orientation section of the instructions for use.)

The safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established.

The use of any synthetic mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh and it is not recommended.

If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh.

For hiatal hernia repair, the use of Phasix™ ST Mesh circumferentially around the esophagus is not recommended.

For hiatal hernia repair, the use of Phasix™ ST Mesh to bridge the hiatus is not recommended.

The safety and effectiveness of Phasix™ ST Mesh in the following applications has not been evaluated or established: pregnant women, pediatric use, neural and cardiovascular tissue.


PRECAUTIONS
The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.


ADVERSE REACTIONS
In preclinical testing, Phasix™ ST Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance.
The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, inflammation, allergic reaction, hemorrhage, extrusion, erosion, migration, fistula formation and recurrence of the hernia or soft tissue defect. Possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use. Dr. Steven DeMeester is a paid consultant for BD.

BD-32058



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