 Presenting the findings of TALENT trial, Dr.

Patrick Serruys,
said, “Safety and efficacy of Supraflex SES with ultra thin
struts and biodegradable polymer were compared with
Xience EES in all comers-population. Supraflex was found to
be non-inferior to the Xience for DOCE (device oriented end
points) at 12 months in an all comer-population* with a lower
rate of CI-TLR** in the per protocol analysis.”
 Supraflex, a cardiac drug eluting stent designed and
manufactured in India has been confirmed to be at par with
Abbott’s Xience through an investigators-driven study called
'TALENT'.
 The TALENT trial included mean patient age of 65 years, and
about three-quarters were men, with about 40% of patients
presenting with stable angina and 60% with Acute Coronary
Syndromes (ACS). The rate of a device-oriented composite
endpoint of cardiac death, target-vessel MI, and clinically
indicated TLR at 12 months was 4.9% with Supraflex and
5.3% with Xience, a difference that met criteria for non-
inferiority (P< 0.001).
 In a per protocol analysis Supraflex had better efficacy as
compared to Xience. The rate of clinically driven re
procedure rate was 1.2% vs 3.1% which was also statistically
significant. The lower the re procedure rate the better it is.
 Supraflex has advanced features like biodegradable
polymer and ultrathin strut* (60µm) thickness compared to
81 µm strut thickness and biostable polymer coating of
Xience.
 Supraflex™ has the lowest strut (60µm) thickness among all the available
sirolimus eluting coronary stents, without compromising radial strength

 Flexible ‘S’-link provides unparalleled flexibility, deliverability and vessel

conformability allowing you to deal with the most complicated anatomies.

Key Features and benefits:

 Integrated markers for optimal low-profile
 Serpentine struts allow homogenous stress distribution upon expansion
 L605 cobalt-chromium alloy allows thin strut design (60µ) better corrosion
resistance and MRI compatibility
 Flexible tip offers low entry profile for exceptional crossability
 Extremely low crimped profile on balloon enhances deliverability
 S-Link offers better trackability
 S-Link offers flexibility
Available stent lengths* 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48mm
 Available stent diameters* 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50mm

Stent material Surgical grade L605 Co-Cr alloy

Laser cut from seamless tubing in a serpentine

Stent design pattern

Stent strut thickness 0.06MM (60µ)

Nominal stent
foreshortening <3%

Recoil <4%

Delivery system usable

length 1400mm (140cm)

Single access port to inflation/deflation lumen. A

Delivery system Y adaptor guidewire exit port is located at 25cm from the
ports tip. Designed for guidewire 0.014 inch

Catheter shaft outer

diameter Proximal: 0.72mm, Distal:0.95mm

**NP:6 bar, RBP:16 bar,RBP:14 bar for balloon

diameters 4.0mm and 4.5mm with balloon
Balloon inflation pressure lengths >20mm

Guide catheter 5Fr compatible

Guidewire diameter 0.014 inch

* CE approved for Ø2.00mm to Ø4.50mm with stent lengths 8mm to 48mm

** Assure full deployment of the stent. Deployment pressures should be based on
lesion characteristics

Note: 1F is equivalent to 0.33mm. 1 atm = 1.01 bar

 https://smtpl.com/products/des/supraflex/

Supraflex Cruz
 More than 2,50,000 people with coronary artery diseases have been treated
with Cruz
 Cruz is one of the most trackable stents globally
Mumbai -A leading manufacturer of Coronary stent systems, SMT (Sahajanand
Medical Technologies) today announced that it has received CE* Mark for its highly
deliverable next generation Supraflex stent system, called Supraflex Cruz.

Supraflex Cruz is a Sirolimus-eluting stent built on a Cobalt Chromium Platform

having implanted in more than 2,50,000 patients in India and in selected
International markets over last 3 years. The stent design provides physicians access
to the most difficult and tortuous lesions with ease. The stent retains all the benefits
of the Supraflex stent, viz, Ultrathin strut thickness (60 microns for all diameters and
lengths), blend of proprietary biodegradable polymers to release the drug, very thin
layer of polymers, high radial strength, and low crossing profile.

 Cruz promises superior deliverability with an innovative design of dual Z link

connecting valley to valley and better side branch access. With the help of Cruz,
complex cases can be finished faster and harmful exposure of radiation to the
physician will be reduced. Also, the trackability will void the need for additional
hardware.

Clinical studies on Cruz (Current and Future)

Supraflex Cruz has undergone multiple clinical studies including the most advanced
OCT studies (Sibi and Taxco OCT study) showing healing pattern post-deployment
of the stent. Faster endothelization represents better healing pattern.

Sibi OCT study demonstrated that Supraflex Cruz had close to 91%
endothelialisation in 35 days. In the Taxco study, Supraflex Cruz was compared with
market leading Everolimus-eluting stent in a head to head comparison at 6 months.

The study showed both the stents had more than 97% endothelialisation at 6
months.

Further clinical studies on Cruz are planned across Europe, India, Latin America and
the rest of the world in the coming 2 years. These clinical trials will test Supraflex
Cruz in a challenging patient population in Randomised clinical trials including
Multivessel, Diabetics, ACS, High Bleeding Risk patients and Fragile patients (age
over 75years).

Supraflex Cruz will help the patient and the doctors by -

 Decreasing the procedure time for physicians thereby reducing the intake of
harmful radiation.
 ensuring lesser complications during the complex procedure due to better
deliverability of the stent.
 Saving more lives: Physicians are now able to treat a more challenging
patient population which were left untreated or referred to Bypass surgery.
*The CE Mark indicates that the product satisfies requirements of EU Directives (EU:
The European Union) and all products need to be CE certified to be sold in Europe.

About Supraflex Cruz

Cruz design provides physicians access to difficult and tortuous lesions which were
very challenging in their practice. The stent retains all the benefits of the Supraflex
stent or the previous “Supra” Family of stents, viz, Ultrathin strut thickness (60
microns for all diameters and lengths), blend of proprietary biodegradable polymers
to release the drug, very thin layer of polymers, high radial strength, low crossing
profile. The Supraflex Cruz has a very large and extensive size matrix. 1 set consists
of 88 skus and covers diameters from 2.0 mm to 4.5 mm and lengths from 8 mm to
48 mm. This size matrix ensures that the physician and the patient do not need to
make any compromise of accommodating a shorter or a longer stent inside the
coronaries.

 https://www.tctmd.com/news/talent-indian-made-supraflex-des-stands-well-against-xience-
all-comers
 https://www.ncbi.nlm.nih.gov/pubmed/30827782

ADVANTAGE:

The Resolute Onyx stents should not be expanded to a diameter beyond the maximum labeled
diameter listed on the label per the IFU. Do not dilate the 2.0- mm stents to greater than 3.25
mm. Postdilatation required for overexpansion.

HOW ARE WE INFERIOR?

1. They have more size both in terms of length and diameter.

2.