![]() ![]() ![]() In April of 2015, we entered into an agreement with All Of It Scandinavia AB to distribute a radial arm board in the U.S. under the name VSI Radial™ Introducer Sheath. LePu Medical manufactures the product, which we sell in the U.S. distribution rights to a line of introducer sheaths designed for use in radial catheterizations. In December 2014, we expanded our relationship with LePu Medical to include exclusive U.S. The Vasc Band is placed around the patient’s wrist after a radial catheterization procedure and uses an inflatable compression band to assist hemostasis. distribution agreement with LePu Medical Technology (Beijing) Co., Ltd. In May of 2013, we launched the Vasc Band radial compression device under an exclusive U.S. The Accumed wrist positioning splint consists of a molded plastic brace that simplifies access to the radial artery by holding the hand, wrist, and forearm in an appropriate, comfortable position. In June 2012, we acquired the Accumed™ wrist positioning splint device from Accumed Systems, Inc. Managing intellectual property assets and claims is a significant challenge for our business.ĭuring 2012, we implemented our strategy of launching products that address the significant growth opportunity in the radial access market. On July 30, 2014, we reached an agreement with Boston Scientific Corporation to settle a patent and copyright infringement lawsuit brought by us against Boston Scientific Corporation related to a competitive product to our GuideLiner ® guide extension product on confidential terms. On October 14, 2013, we reached an agreement with Terumo Corporation and Terumo Medical Corporation (Terumo) to settle a patent and trademark infringement lawsuit brought by Terumo against us related to a prior version of our Vasc Band™ radial compression device in exchange for a one-time payment to Terumo in the amount of $812,500. To maximize the profitability of new product ideas, we seek patent protection for those product design and method concepts which we believe have the potential to provide substantial product revenue. The interventional medical device industry is characterized by numerous patent filings and litigation claims made to protect new and evolving product ideas. Based on our analysis of the publicly-available sales figures from selected companies that participate in the cardiovascular device sector, we estimate the worldwide market for interventional medical devices used in cardiovascular procedures in 2015 exceeded $15 billion. Although worldwide demographic factors, including the growing incidence of cardiovascular disease, seem to favor long-term growth in the number of interventional procedures, we believe that the recent structural pressures on utilization rates are likely to continue and to result in relatively flat catheterization volumes for the foreseeable future. Operators should be aware of the potential complications associated with GuideLiner use.During the past few years, the number of catheterization procedures performed worldwide has been declining gradually due to a number of factors – among them, the effects of weak economies on overall health care utilization rates, efforts by third-party payers to lower costs associated with medical procedures, investigations by government agencies into potential over-utilization of procedures, the implementation by hospitals of policies designed to reduce the incidence of unnecessary procedures in the wake of these outside investigations, and new diagnostic imaging and functional assessment modalities that more effectively screen patients to determine the need for treatment. Use of the GuideLiner catheter facilitated successful completion of PCI procedures in a majority of patients with complex lesions. The overall technical success rate of the GuideLiner was 88%. The majority of lesions were types B2 or C (98%), calcified (86.3%), with proximal tortuosity (88.6%). The mean age was 68.4 ± 11.2 years and 82% were male. The GuideLiner was utilized in 307 (317 lesions) of 6105 PCI procedures performed at our institution during the study period. Indications for use of the GuideLiner, and angiographic and procedural data specific to the device were also collected. Demographic and procedural data were obtained from an institutional prospective data registry. We collected data from all patients in whom the GuideLiner was used to facilitate PCI between Apand Decemat a tertiary referral center in Toronto, Canada. Therefore, we aim to report the indications, success, and efficacy of GuideLiner use in treating complex lesion subset in the present study. There is paucity of data about the efficacy of this device in complex PCI. Minneapolis, MN) is a rapid exchange guide catheter extension system. The GuideLiner® catheter (Vascular Solutions, Inc. ![]() Percutaneous coronary intervention (PCI) procedures are increasingly performed on complex tortuous and heavily calcified coronary lesions. ![]()
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