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For cardiovascular suture,
THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC. ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. ALWAYS FOLLOW THE DIRECTIONS FOR USE
This medical device must be administered by a Healthcare Professional/ This medical device must be implanted by a Healthcare Professional.
From Ti-Cron™ and Surgipro™ II sutures to Cardiopoint™ needles and Oval pledgets, today’s portfolio is more than you may realise. It’s leveled up to inspire hard-working performance for both you and your patients.
When it comes to slip resistance and knot security, there's a reason surgeons use braided Ti-Cron™ sutures.1,6,†,‡
Cardiopoint™ needle is sharper, stronger and offers enhanced control and consistency.2,§ No wonder 86 percent of surgeons are willing to use Cardiopoint™ CV-24, the latest needle in the portfolio.5,Ω
Built to be stronger with better performance3,‡‡,§§ — Surgipro™ II suture is what you and your patients deserve. Easy to remove7 from NuCoat™ retainers, and with a 23 percent higher willingness to switch.5,ΩΩ
Compared to rectangular pledgets, Oval pledgets conform better to the shape of the anatomical structure, and result in less foreign mass in the body.4
Figure 1 Individual Value Plot of all firm pledgets tested. Industry reference A* pledgets had two occurrences where the pledget broke before the suture (both are considered outliers based on Grubb’s Outlier Test at a significance level of p<0.001). However, all pledgets passed the criteria outline.1,†
Figure 2 Individual Value Plot of all soft pledgets tested. Medtronic 3x6 mm soft pledgets had one outlier as determined by Grubb’s Outlier Test.1,†
If it's been a while since you've considered our complete cardiovascular core suture portfolio, contact a Medtronic rep today and see why as your solutions partner – we're all heart.
This material is for Healthcare Professionals in countries with applicable health authority product registrations.
Important: Always refer to the Instructions For Use (IFU) packaged with the product/e-IFU for complete instructions, indications, contraindications, warnings, and precautions.
Ti-Cron™ polyester non-absorbable sutures elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. Ti-Cron™ can be sold with PTFE Pledgets. The use of pledgets is contraindicated in patients with known sensitivities or allergies to its components. Ti-Cron™ polyester non-absorbable sutures require adequate knot security which involves the acceptable surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon.
Surgipro™ non-absorbable sutures elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. The use of additional throws may be particularly appropriate when knotting monofilaments.
Acceptable surgical practice must be followed. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Reuse, reprocessing and/or resterilization of this device may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.
The use of pledgets is contraindicated in patients with known sensitivities or allergies to its components.
†Compared to ETHIBOND EXCEL®* size 0.2-0, 2, and 5. May not be indicative of clinical performance.
‡Compared to ETHIBOND EXCEL®* size 2-0. May not be indicative of clinical performance.
§Compared to Ethicon BB, RB1, and SH2 needles.
Ω Based on surgeon VOC lab, may not be indicative of clinical performance.
††Compared to legacy Medtronic needles with Surgalloy, may not be indicative of clinical performance.
‡‡Compared to previous generation of Surgipro™ sutures made with Poly (Ethylene Glycol) Distearate; measured by straight pull strength.
§§Based on benchtop test data; may not be indicative of clinical performance
ΩΩBased on surgeon double blinded VOC porcine tissue lab; may not be indicative of clinical performance.
†††Over rectangular pledgets.
‡‡‡Bench test data. May not be indicative of clinical performance.
References:
1. Based on internal test report #RE00100396, Ti-Cron™ suture 2-0 knot security benchmark testing. August 19, 2015. CL-007061.
2. Based on validation report #RE00172196, Sharpie II Cardiopoint™ Needle Benchmarking. November 19, 2018.
3. Based on validation report #RE00073496, Optimized Diameter Surgipro™ II 4-0 Evaluation. 01/24/2017. Based on validation report #RE00115198, Surgipro™ II 4-0 Top Performing DOE Sample Validation. 10/10/2017. Based on validation report #RE00167893,
Surgipro™ II 5-0 DOE Sample Validation. 09/04/2018. Based on validation report #RE00167894, Surgipro™ II 6-0 DOE Sample Validation. 09/04/2018. Based on validation report #RE00167895, Surgipro™ II 7-0 DOE Sample Validation. 09/25/2018.
4. Based on survey of 6 CV surgeons in two cities - NYC and Chicago. HMV Report. Pledget. Usability lab focus group, conducted on June 10, 2015. — 06-10-15 , 06-10-16, 06-10-17, 06-10-18, 06-10-20, 06-10-22, 06-10-25, 06-10-28.
5. Based on validation report #RE00171206 with 13 Surgeon Evaluation of Surgipro™ II CV Suture Strength. 09/18/2018.
6. Based on internal test report #RE00094876, Ti-Cron™ suture 2-0 knot security benchmark testing. August 19, 2015. CL-007062.
7. Based on validation report #re00073496, optimized diameter Surgipro™ II 4-0 evaluation. 24th January, 2017. Based on validation report #RE00115198, Surgipro™ II 4-0 top performing DOE sample validation. 10/10/2017.
8. Medtronic R&D Engineering Report. Report Number: RE00017984. Determination of Pledget Removal Force. Aug. 7, 2015.
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