A Prospective Multicenter Randomized Trial to Assess the Effectiveness of the MagicTouch Sirolimus-Coated Balloon in Small Vessels: Rationale and Design of the TRANSFORM I Trial.

Aims: The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD).

Study Design: The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm).

Biological effect on restenosis and vascular healing of encapsulated paclitaxel nanocrystals delivered via coated balloon technology in the familial hypercholesterolaemic swine model of in-stent restenosis.

Aims: The aim of this study was to evaluate the biological efficacy of a novel lower-dose (2.5 µg/mm2) encapsulated paclitaxel nanocrystal-coated balloon (Nano-PCB) in the familial hypercholesterolaemic swine (FHS) model of iliofemoral in-stent restenosis.

Methods And Results: Nano-PCB pharmacokinetics were assessed in 20 femoral arteries (domestic swine).

Unprotected distal left main bifurcation drug eluting stent restenosis: first successful experience with simultaneous kissing balloon dilatation using sirolimus coated balloon.

Treatment of unprotected left main (ULM) in-stent restenosis (ISR) in patients with prior drug eluting stent implantation is challenging. Treatment usually involves complex stenting procedures or bypass grafting. Drug coated balloon (DCB) is relatively new concept which is usually used in treatment of ISR.

Preclinical evaluation of a novel abluminal surface coated sirolimus eluting stent with biodegradable polymer matrix.

Background: Second generation of drug eluting stents (DES) has attempted to improve safety using abluminal sirolimus drug delivery with biodegradable polymers matrix. The present preclinical study was designed to investigate the safety and efficacy profile of Abluminus™ stents (SES). This is a new coronary stent with sirolimus and biodegradable polymer matrix coated on abluminal stent and balloon surface.

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries.

Background: Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors).

Methods: In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix).

Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter.

Drug-eluting stents have proven to be effective in reducing the risk of late restenosis. In order to achieve a controlled and prolonged release of the antiproliferative agent, current drug-eluting stents utilise various biodegradable as well as non-erodible polymeric blends to coat the stent surface and to serve as drug carriers. The utilisation of polymeric compounds in current drug-eluting stents may eventually limit their performance as well as their clinical applicability due to the potential induction of undesirable local reactions.

An outbreak of norovirus infection in a bone marrow transplant unit.

Background: Norovirus is a single-stranded RNA virus belonging to the Caliciviridae family.

Methods: Our observational cohort study aimed to describe a nosocomial outbreak of norovirus on a bone marrow transplant (BMT) unit.

Results: Six of 8 BMT patients with increased liquid stools tested positive for norovirus: 4 had new onset diarrhea; 2 had acute exacerbations of chronic diarrhea caused by graft versus host disease.