Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label

Sindacati di voto a "tempo indeterminato" e diritto di recesso dei paciscenti nelle società a responsabilità limitata

L'articolo esamina la disciplina del recesso del socio da sindacati di voto a tempo indeterminato nella s.r.l

The role of comparative law in shaping corporate statutory reforms

This Essay discusses how comparative law played and plays a role in the statutory development of corporate laws. The influence of laws of other systems on the development of statutory law is common, explicit, and represents a tradition that accompanied legal reforms since the very beginning of the development of legislation. Focusing on modern corporate law, I argue (but the argument could be extended to many other legal fields) that it is necessary to distinguish two basic ways in which comparative law influences legal reforms in one particular jurisdiction. The first one is through regulatory competition among different systems. In order to make one system more competitive and attractive, or to remove disadvantages affecting the economic development of one system, legislatures can respond to foreign threats by changing their laws either borrowing rules and institutions from other systems (legal transplants), or by adopting rules designed to protect their interests vis-à-vis the effects of foreign law. The second “channel” through which comparative law plays a role in shaping local rules is a top-down harmonization process. Different reasons can suggest a harmonized regulation of corporate law: the need to create a common market in which all economic actors can operate in a leveled playing-field, the removal of barriers to commerce among states, the desire to reduce regulatory arbitrage, the goal of ensuring to all constituencies of different jurisdictions a similar level of legal protection, and so on. Typically, international agreements can foster harmonization, and the paradigmatic example of this are corporate law (and securities regulation) directives in the European Union, but examples are also present in the U.S.: consider, for example, the Sarbanes-Oxley Act of 2002 that introduced some common rules in the field of corporate governance at the federal level, or the role played by the Model Business Corporation Act. The rules contained in these legal instruments are rarely developed out of the blue. Generally they take into account regulations already existing in one or more jurisdictions, and through a negotiation process tend to extend them also to other systems. In this Essay I will discuss several examples of how comparative law influenced the development of statutory corporate law either through the mechanism of regulatory competition, or through harmonization; both in the U.S. and in the European Union. I will conclude by considering the role of comparative law in corporate law statutory evolution

Un'azione, un voto: un principio da abbandonare?

L'articolo prende in esame la disciplina introdotta in Italia nel 2014 in materia di azioni a voto multiplo, sulla scorta di un raffronto con l'esperienza statunitense e dell'analisi di alcuni studi empirici

Issuing new shares and preemptive rights : a comparative analysis

The question of whether the corporate law of Europe and America are converging is still largely unanswered. One fundamental area in which the two systems diverge concerns how they regulate the issuing of new shares, in particular preemptive rights, a problem rarely addressed by comparative corporate law scholars. This essay fills that gap by examining the major comparative differences between the approaches followed on the two sides of the Atlantic, and offers some possible explanations for this divergence

When Market Abuse Rules Violate Human Rights: Grande Stevens v. Italy and the Different Approaches to Double Jeopardy in Europe and the US

The Article examines a groundbraking decision of the ECJ, hoding that combining criminal and "administrative" sanctions in market abuse cases can violate the double jeopardy prohibition of the ECHR, and also discussing due process protections for the accused. The article examines critically the decision and its consequences, and compares the European situation with the one existing in the US

The Disappearing Taboo of Multiple Voting Shares: Regulatory Responses to the Migration of Chrysler-Fiat

This article examines the reform on multiple voting shares enacted by the Italian Government in 2014. It explores the relevant rules in a comparative perspective, considering similar experiences in Europe and the US, and discussing the empirical evidence on the effects of MVSs, especially in listed corporations. It also illustrates some interpretative issues raised by the new Italian rules, and the possible motivations of the Italian legislature in taking this step also vis-à-vis the planned privatization of some large state-owned enterprises

Il risarcimento del danno da deliberazione assembleare invalida a favore dei soci di minoranza non legittimati a impugnare

L'articolo esamina il problema del risarcimento dei danni a favore di azionisti di minoranza pregiudicati da una deliberazione assembleare invalida i quali tuttavia, in base alla disciplina vigente, non sono legittimati a impugnare la delibera in quanto titolari di una soglia di azioni inferiore al minimo richiesto dalla legge per accedere alla tutela demolitoria

Why shareholders’ Agreements are not used in U.S. listed Corporations : a conundrum in search of an explanation

This short essay, prepared as the text of a talk for a conference on shareholders’ agreements, examines what I consider one of the most puzzling and overlooked issues of US corporate law and securities regulation. The issue is why agreements among shareholders are not often used as control enhancing devices among American listed corporations. I offer a few ideas on this question, not providing a conclusive answer, but rather exploring some hypothesis and suggestions for further research. In order to do that, I divide my discussion in two parts. First, I quickly overview the substantive regulation of shareholders’ agreements in the United States, focusing in particular on Delaware law and on the Model Business Corporation Act. Second, I concentrate on the issue of the use – or, better, limited use – of shareholders’ agreements in listed corporations. I offer some new possible explanations for the limited use of these type of covenants in the United States