BioMime Morph Research Articles

One-year outcomes of novel BioMime Morph tapered stent in long and multiple coronary artery lesions.

Even with the immense progress achieved in the field of percutaneous coronary interventions (PCIs), treatment of diffuse long atherosclerotic coronary artery disease continues to remain a challenge for durable outcomes. The downstream reduction in diameter along the lesion length of a coronary artery may compel the cardiologist to use either 2 overlapping stents of different diameters or a single long stent leading to stent-vessel mismatch at the edges. Recently, Meril Life Sciences Pvt. Ltd., India, has introduced a long-tapered sirolimus-eluting stent (SES) system, BioMime Morph, which conforms to the normal tapered geometry of coronary arteries along with adequate lesion coverage. In this study, we aimed to provide real world experience regarding the safety and efficacy of the BioMime Morph SES over a follow-up of one year. This was a single center, retrospective study involving 172 participants who underwent PCI with the BioMime Morph SES. Mean length of the target lesion was 34.4±10.4 mm, and mean stent length was 53.2±8.7 mm. The most frequent revascularized vessel was the left anterior descending artery (LAD) in 97 lesions (54.4%). Major adverse cardiac events (MACE) (defined as a composite of target vessel myocardial infarction, target lesion revascularization, and death due to a cardiac cause) at 1, 6, and 12 months were seen in 4 (2.3%), 7 (4.0%), and 8 (4.7%) patients, respectively. Overall, 5 cardiac deaths and 2 definite stent thrombosis were observed in the study. The study suggests that the novel BioMime Morph SES is an effective and a safe option for PCI in the treatment of long diffuse atherosclerotic lesions.

Feasibility and Outcomes of Left Main to Branch Vessel PCI with Novel Tapered Coronary Stent in a Tertiary Care Centre: A Real World Experience.

To assess the safety and efficacy of Novel tapered (BioMime™ Morph) sirolimus- eluting stent (SES) for left main PCI in a real-world scenario. Currently, no data is available on clinical usefulness of tapered ultrathin stents in left main PCI. This was a prospective, non-randomised, single centre study carried out between February 2018 and May 2020 at a tertiary cardiac care centre in southern India. The study included patients treated with BioMime Morph tapered stent for distal de novo LMB lesion or ostial LAD/LCX lesions with significant size disparity between reference segments based on the eligibility criteria. Primary endpoint of the study was the cumulative incidence of major adverse cardiovascular events (MACE) composed of cardiac death, myocardial infarction, and clinically driven target-lesion revascularisation at follow-up. A total of 41 patients (average age of 54.83±9.81 years) were included in the study. Average SS-2 score was 23.17±5.42. Majority of the lesions (n=31; 75.61%) were of medina class (0.1.0). Provisional single stent strategy was adopted for treatment of LMB lesions. TIMI flow-3 was achieved in 40 patients (97.56%). Median clinical follow-up was 20 months (range 6-34 months). There was no periprocedural complication or MACE during follow-up. Tapered stents may be an acceptable alternative for LM intervention in an anatomical subset of patients with tapered vessels.

Immediate and mid-term outcomes of novel BioMime Morph Sirolimus eluting tapered stent in patients with long coronary artery lesions

Immediate and mid-term outcomes of novel BioMime Morph Sirolimus eluting tapered stent in patients with long coronary artery lesions

Use of BioMime Morph stent in treating left main triple vessel disease: a case report

BackgroundDiffuse long coronary lesions require long overlapping stents which produce less than optimal long-term results. Sizing of long stents becomes difficult owing to tapering of coronaries and overlapping with excessive metal which makes restenosis a nagging problem on long-term follow-up. The optimal stent sizing becomes even more important when left main (LM) needs to be treated along with left ascending artery (LAD) or left circumflex artery (Lcx). The chronic total occlusions (CTO) represent other complex diffuse coronary lesions which not only require higher expertise and better hardware but also usually long lengths of overlapping stents. The long-tapered sirolimus-eluting stent system (BioMime Morph) has been successfully used in long diffuse lesions in individual coronaries including CTO but the use of the same in LM-LAD/LM-Lcx diffuse lesions has not been explored well where its tapered design can really be favourable.Case presentationWe here present a case of a 51-year-old hypertensive male presented with NSTEMI and angiography showing left main triple vessel disease with CTO of right coronary artery (RCA). We successfully stented the LM-LAD and RCA (staged) using a long-tapered BioMime Morph system. IVUS was used for optimising the LM-LAD stent. At 6 months follow-up, the patient was doing well on double anti-platelets.ConclusionComplex coronary disease, involving the left main and LAD diffusely and CTO of RCA, can be well managed by using a single long-tapered stents thereby avoiding multiple stenting strategy. The stents with decremental diameter will provide better adaptation to the vessel size and their natural tapering. The usage of intravascular imaging helps in better optimisation of stents

P2804Initial experience with the novel BioMime Morph 40–60 mm long sirolimus-eluting tapered stent in long coronary lesions

Abstract Aims Aims: Long lesions treated with overlapping stents has been reported to be associated with healing problems and/or adverse events. The novel BioMime Morph is a 40, 50 and 60 mm long sirolimus-eluting cobalt chromium stent (65 μm strut thickness, biodegradable polymer) with a tapered design (0.5 mm taper from proximal to distal end) and is available in the following proximal and distal diameters (2.75–2.2 5mm, 3–2.5 mm and 3.5–3 mm). It can be a novel alternative for treatment of long coronary lesions, overcoming the limitations of overlapping stents. Methods and results Methods: Data was evaluated from our centre's prospective BioMime Morph database from August 2016 - January 2019. Primary endpoint was device oriented composite endpoint (DOCE: cardiac death, TV-MI, TLR and TVR). Secondary endpoints were technical (successful Morph implantation) and procedural success (successful procedure with Morph without in-hospital MACE). Results 103 patients had BioMime Morph stents implanted, with mean follow up of 411 (±214) days and a mean age of 66 (±11) years. Co-morbidities included hypertension (58%), hypercholesterolemia (38%), diabetes mellitus (28%), PVD (2%), CVD (5%), CKD (12%), previous MI (17%), smoking (40%) and positive family history (20%). There was history of previous PCI in 18% and CABG in 4%. Indication for PCI was predominantly ACS (78% including 13% STEMI), 15% were CTOs. 80% of the procedures were performed via radial access using 5–6F sheath in 73%. Vessels treated included LAD (43%), Cx (12%) and RCA (45%). Pre-dilatation was performed in 96% including use of non-complaint balloons in 51%, scoring balloons in 12% and rotablation in 4%. Post-dilatation was performed in 99%. Buddy wire was used in 41% while a guideliner used in 13%. Technical success (secondary endpoint) was achieved in 100 whilst procedural success was achieved in 96% (4 cases of contrast induced nephropathy). Cumulative DOCE (primary endpoint) was % (cardiac death 1%, TV-MI 1%, definitive ST 0%, possible ST 1%, TLR 2% and TVR 2%). OCT follow up at 1 month, 3 month and 6 months in 2 patients showed endothelialisation even at 1 month. Conclusions Our initial experience of the use of the novel BioMime Morph tapered DES for treatment of long coronary lesions exhibit promising results in short to medium follow-up. Elution of the drug in 1 month along with biodegradable polymer and ultra thin struts potentially helps early healing and raises the possibility of short DAPT even in these complex long lesions. BioMime Morph stents can potentially be an alternative to overlapping conventional stents for treating long coronary lesions.

Clinical experience with 12-month follow-up in patients after implantation of a novel long-tapered sirolimus drug-eluting stent.

IntroductionLong lesions contribute to a significant number of percutaneous coronary interventions.AimTo assess the efficacy and safety of a novel long-tapered drug-eluting stent (DES) at a 12-month follow-up (FU) in patients with long coronary atherosclerotic lesionsMaterial and methodsA prospective clinical cohort study was conducted in 32 patients who underwent percutaneous coronary intervention using a BioMime Morph tapered stent (Meril Life Sciences, India). The patients were followed for 3, 6, and 12 months. The safety endpoints were death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and MACE and/or major bleeding.ResultsMean lesion length was 48 mm (range: 35–70 mm) measured via quantitative coronary analysis (QCA). In most cases, the target lesion was located in the LAD (68.75%). A GuideLiner catheter (Vascular Solutions Inc., MN, USA) was used in 12.5% of procedures; buddy-wire technique in 9.4% of cases. Bifurcation lesions were treated in 40.6% of cases. Additional stent implantation was needed in 56% of the procedures (25% of cases due to proximal or distal dissection, or due to insufficient stent length in 31% of cases). On 12-month FU we observed 1 TLR (3.1%), 1 TVR (3.1%), and 1 non-cardiovascular death.ConclusionsThe long sirolimus-eluting stent with tapered structure was characterized by good deliverability in long coronary lesions, although in some cases “buddy wire” or extension microcatheter use was necessary. Follow-up at 3, 6, and 12 months showed no significant major adverse cardiovascular events related to the device.

TCTAP A-107 Real World Experience of the Biomime Morph Tapered Stent in a Tertiary Care Hospital

The Biomime Morph (Meril life Sciences, Gujarat, India) is a Sirolimus eluting tapered stent approved for use in India. It is available in four lengths {30 mm, 40 mm, 50 mm and 60 mm} and four diameters {2.75 mm tapering to 2.25 mm, 3 mm tapering to 2.5 mm, 3.5 mm tapering to 2.75 mm, and

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BackgroundWhen coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world’s first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario.MethodsThis was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up.ResultsOut of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient.ConclusionsThe present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

Treatment of long coronary lesions with single stent: BioMime Morph sirolimus-eluting tapered coronary stent system

Treatment of long coronary lesions with single stent: BioMime Morph sirolimus-eluting tapered coronary stent system

Experience of the management of complex long lesion by indigenous Biomime Morph tapering stents

Experience of the management of complex long lesion by indigenous Biomime Morph tapering stents

TCTAP C-263 Management of Long Complex CTO in LCX by Indigenous Biomime Morph Tapering Stents from Meril

### Patient initials or identifier number Mr S S ### Relevant clinical history and physical exam ### Relevant test results prior to catheterization ### Relevant catheterization findings A coronary angiography shows double vessel disease involving LAD (85% narrowing with diagonal ostial lesion

TCTAP A-154 Experience of the Management of Complex Long Lesion by Indigenous Bio-mime MORPH Tapering Stents

Coronary artery lesions are often long and tortuous necessitating overlapping stents during angioplasty. Indigenous Biomime MORPH tapering stents from Meril are a new alternative. This prospective, observational study documents our experience with the use of Meril Biomine Morph stent in varied