SMT Announces CE* Mark for the Most Deliverable Stent 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 rest of the world in 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 75 years).
Talking about the latest announcement the CEO of SMT, Ganesh Sabat said, "We look forward to working with physicians across Europe to offer this highly deliverable drug eluting stent to the thousands of patients who would have been unable to undergo PCI due to complex anatomy. "
The company recently completed Talent trial in Europe involving 23 centres in 7 countries on 1435 patients which was published in the most renowned medical journal 'The Lancet'. In this trial, SMT's Supraflex came out with flying colors against the market leader stent, showcasing best in class safety and efficacy in global patients' population. Also, this trial was presented at an US Cardiology conference TCT MD in the late breaking session.
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 complex procedure due to better deliverability of the stent.
- Saving more lives: Physicians are now able to treat 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 an 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 consist of 88 skus and covers diameters from 2.0 to 4.5 and lengths from 8 mm to 48 mm. This size matrix ensures that the physician and the patient does not need to make any compromise of accommodating a shorter or a longer stent inside the coronaries.
SMT is a global medical device company committed to make advanced medical technologies accessible to everyone around the world. With presence in 70 countries, SMT has achieved recognitions from the Ministry of Health Sciences & Technologies for its tremendous contributions in the field of Coronary healthcare. SMT also pioneered the introduction of biodegradable polymer in the cardiovascular segment. SMT will continue the journey to heal hearts around the world by creating healthcare future promising for everyone.