Many heart conditions such as Unstable angina, myocardial infarction within six weeks and aortic or peripheral vascular surgery place a patient in a high-risk category for perioperative cardiac complications. We provide pre-surgical clearance for adult patients with or without a known history of heart...
No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or,...
Define Preclearance Procedures. means that a proposed transaction shall be precleared in writing by a Review Officer prior to proceeding with a transaction. In determining whether to grant such preclearance, the Review Officer shall refer to Section V, b
Review of Medical, Surgical, and Psychiatric Histories Many chronic medical conditions such as diabetes, hypertension, psychiatric illness, and thyroid disease have implications for pregnancy outcomes and should be optimally managed before pregnancy (Table 1). Consideration may be given to referral to a...
"The approval of the KS-Ni Preloaded IOL Injector continues to highlight the rapid fire launch of products that leverage STAAR Japan's expertise in the area of preloaded delivery systems for foldable IOLs," said Barry G. Caldwell, President and CEO of STAAR Surgic...
Conditions of Use (i.e., Environment of Use)– A description of proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient. This section should ...
Surgical resection is a common therapeutic option for primary solid tumors. However, high cancer recurrence and metastatic rates after resection are the ma
The only treatment for CIN2/3 is surgical treatment, and most surgical treatments performed in Japan are conization, LEEP, or laser vaporization. In Japan, approximately 15,000 women undergo this surgery annually, and the peak age at which women undergo this surgery is the early 30s. With the...
In addition, PDT can be used intra-operatively just after the surgical removal of cancers which may help elimination of the residual tumor cells. During the past 30 years, PDT has been employed in the treatment of many tumor types, and its effectiveness as a curative and...
Formigli, L, et al., “Non-Surgical Flushing of the Uterus for Pre-Embryo Recovery: Possible Clinical Applications”, Centre for Reproductive Medicine and CECOS-Milan, Viale Umbria, 44, 20135 Milano, Italy, Human Reproduction vol. 5, No. 3, pp. 329-335, 1990 (7 pages). ...