Tsvh mp 1 ha technology zd1297 rev 11 2014

Page 1


DOCUMENTED CLINICAL SUCCESS Implants with MP-1 HA enjoy outstanding clinical outcomes that further demonstrate the quality and performance of the coating.

100%

100%

97.9%

96.2%

STUDY8 – 429 IMPLANTS

100%

STUDY7– 245 IMPLANTS

CUMULATIVE IMPLANT SURVIVAL RATE 100%

99.6% 93.2%

96.6%

0%

1 Year

5 Years

Documented clinical survival rates for 5,099 Zimmer MP-1 HA coated Implants: • I mplant survival rate mean 98.9% (range from 93.2% to 100%) • F ollow-up times range from 12 to 108 months (mean = 56.6 months)

STUDY11 – 537 IMPLANTS

STUDY10– 3811 IMPLANTS

STUDY9 – 60 IMPLANTS

20%

STUDY6 – 52 IMPLANTS

40%

STUDY5– 19 IMPLANTS

60%

STUDY4 – 97 IMPLANTS

80%

9 Years


ZIMMER DENTAL

HA TECHNOLOGY CHAMPION Zimmer Dental has led the industry in hydroxyapatite (HA) technology for over 30 years. Dental literature has widely documented the ability of HA coatings to increase bone-to-implant contact (BIC), enhance osseointegration and provide a strong platform to bind with the bone.1-2 The innovative MP-1 HA coating is a technological advancement in both stability and performance. The proprietary MP-1 HA coating is unique to Zimmer with features superior to competitive HA coatings.

STUDY7– 245 IMPLANTS

STUDY6 – 52 IMPLANTS

STUDY5– 19 IMPLANTS

STUDY4 – 97 IMPLANTS

80% ZIMMER MP-1 HA BENEFITS 60% BETTER OSTEOCONDUCTIVE POTENTIAL

96.2%

99.6% 93.2%

93.2%

96.6%

STUDY11 – 537 IMPLANTS

97.9%

STUDY11 – 221 IMPLANTS

100%

STUDY10– 3811 IMPLANTS

100%

STUDY9 – 60 IMPLANTS

100%

STUDY8 – 429 IMPLANTS

100%

Highly crystalline HA coatings exhibit more bone apposition than those with lower crystallinity. Zimmer’s MP-140% HA with up to 97% crystalline HA content is significantly higher than the 45-73% crystalline content of the competitive HA coatings tested.3

20%

LESS RESORPTION

To minimize resorption, Zimmer’s HA coating is subjected to a proprietary MP-1 heat treatment that 0% 1 Year 5 Years 9 Years decreases the amorphous content down to 3%1, significantly lower than the 29-62% amorphous content of other commercial HA coatings.3

MORE STABILITY A coating of high crystallinity and low dissolution rate lends stability to the implant bed.2 Calcium dissolution for Zimmer MP-1 HA is lower than other commercially available HA coatings.3

100% Amorphous Content

3% 55%

27%

23%

97%

80% 73%

60% 40% Crystallinity

40%

77%

60% 45%

20% 0%

Competitive implants

Untreated HA implant

Zimmer MP-1 treated HA implant


EARLY SECONDARY BETTER THAN SLACT 100%

Amorphous Content

3%

55%

40%

27%

23%

97%

80% 60% 40%

77%

73%

60%

45%

BIOMECHANICAL EVALUATIONS12 Crystallinity

20%

A study was performed in sheep to compare the stability and bone tissue response of Zimmer’s 0% and implants with Straumann’s SLActive surface. After 3 and 6 weeks of early MP-1 HA implants Competitive implants Untreated Zimmer MP-1 HA implant treated healing, results demonstrated that Zimmer’s MP-1 HA implants achieved significantly better HA implant

stability and osseointegration than Straumann’s SLActive implants. This study3% showed the 100%

following benefits: Amorphous Content

55%

40%

27%

80%

100%

300

MP-1 HABONE FIXATION12 GREATER

91%

23%

SLActive 60%

77%

73%

250

• Zimmer’s MP-1 HA implants achieved 60% 80%

97%

MP-1 HA

262.1

SLActive

significantly higher reverse torque 45%(p<0.01) values after 340% and 6 weeks 60% MP-1 HA than Straumann’s SLActive Surface in SLActive 51.8% Crystallinity this study. 20% 45.3% 40%

Torque (Ncm)

81.3%

217.2

200

MP-1 HA

164.9

150 100

80%

O

Zimmer MP-1 treated HA implant 3

6

Healing Time (weeks)

300

SLActive

250

MP-1 HA

51.8%

40%

SLActive

45.3%

20%

Bone Volume Fraction

164.9

150

• Bone-to-implant contact (BIC) andSLActive bone volume fraction indicate of an implant physically 118.1 anchored in 100 evidence MP-1 HA bone. 50

Bone-to-Implant Contact

262.1

• Zimmer’s MP-1 HA implants achieved significantly higher SLActive BIC and bone volume fraction (BV/TV) (p<0.05) after217.2 3 and 200 6 weeks than Straumann’sMP-1 SLActive Surface in this study. HA

81.3%

60%

0%

SLActive Untreated HA implant 42.1

12 HIGHER BONE TO IMPLANT CONTACT MP-1 HA

MP-1 HA

91%

78.9

0

Bone Volume Fraction

Torque (Ncm)

100%

Bone-to-Implant Contact

118.1

MP-1 HA

• Reverse torque values demonstrate the 0% Competitive implants 50 degree of bone fixation to implant 20% surfaces. 0%

SLActive

0

78.9

SLActive

42.1 O

3 Healing Time (weeks)

6


STABILITY TIVE HISTOLOGICAL EVALUATION12 Bone response to the implant surfaces was conducted by histological evaluations. MP-1 HA coated surfaces exhibited no adverse tissue responses both at 3 and 6 weeks in this study. New bone with osteoclastic and osteoblastic activity indicated active bone remodeling. Interstitial tissues in the HA implant interface region was predominantly mature while the SLActive surface exhibited a less mature marrow closer to implant surface in this study.12

BETTER BONE DENSITY12

MP-1 HA AT 6 WEEKS Newly formed trabecular bone was thick and showed an increase in bone density compared to SLActive in this study.

SLACTIVE AT 6 WEEKS Observed bone density was variable at threaded implant surfaces and within cross sections compared to MP-1 HA in this study.



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