{"id":5230,"date":"2023-05-01T17:01:00","date_gmt":"2023-05-01T21:01:00","guid":{"rendered":"https:\/\/www.bvimedical.com\/us\/?p=5230"},"modified":"2023-04-30T04:02:44","modified_gmt":"2023-04-30T08:02:44","slug":"bvi-announces-complete-enrollment-of-finevision-hp-ide-clinical-study","status":"publish","type":"post","link":"https:\/\/www.bvimedical.com\/us\/bvi-announces-complete-enrollment-of-finevision-hp-ide-clinical-study\/","title":{"rendered":"BVI Announces Complete Enrollment of FINEVISION\u00ae HP IDE Clinical Study"},"content":{"rendered":"\n

WALTHAM, MA – May 1, 2023 (GLOBE NEWSWIRE)<\/strong> \u2014 BVI, a diversified global ophthalmic device company, today announced it has completed enrollment of its U.S. Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, FINEVISION\u00ae HP. <\/p>\n\n\n\n

The milestone marks the final implantation of the 539th<\/sup> patient enrolled in the prospective, multicenter, randomized, masked, controlled IDE clinical study.  Patients will now be followed to evaluate the safety and performance of the FINEVISION HP intraocular lens, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.<\/p>\n\n\n\n

BVI has one of the most comprehensive ophthalmic surgery portfolios in the industry and is committed to expanding its availability globally.<\/p>\n\n\n\n

\u201cWith the IDE clinical study completing both the enrollment and implantation phase in less than 12 months, we are pleased with our momentum and acknowledge the patients and clinical investigators for their commitment to the trial,\u201d said Devang Shah, Ph.D., BVI Senior Vice President, Business Operations.<\/p>\n\n\n\n

Shervin Korangy, BVI President and CEO, added, \u201cAchieving this milestone represents an exciting and significant step towards bringing our IOL technology to US patients and surgeons.  This trial is the first of a series of studies on innovative ophthalmic devices that BVI will be undertaking in the U.S. in the coming years.\u201d<\/p>\n\n\n\n

FINEVISION\u00ae HP is a hydrophobic trifocal IOL and the third generation in the FINEVISION\u00ae family, featuring BVI\u2019s proprietary hydrophobic material and two novel patented CoPODize\u2122 technologies enabling Convolution and Apodization concepts on the entire optic surface.<\/p>\n\n\n\n

CAUTION<\/strong>  FINEVISION\u00ae is CE Marked since 2010.  FINEVISION\u00ae HP is an Investigational device in the United States. Limited by Federal Law to investigational use; Pending PMA, not available for sale within the United States. <\/p>\n\n\n\n

About BVI<\/strong><\/p>\n\n\n\n

BVI\u00ae is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. BVI supports surgical teams in more than 90 countries worldwide, either directly or through its network of trusted distributors. BVI trusted brands include: Beaver\u00ae (Knives and Blades), Visitec\u00ae (Cannulas), Malosa\u00ae (Single-Use Instruments), Vitreq\u00ae (Vitreoretinal Surgical Products) and PhysIOL\u00ae (Premium IOLs).<\/p>\n\n\n\n

Contacts<\/strong><\/p>\n\n\n\n

BVI<\/strong><\/p>\n\n\n\n

Andrew Dawson<\/p>\n\n\n\n

Corporate Communications<\/p>\n\n\n\n

adawson@bvimedical.com<\/a><\/p>\n\n\n\n

Investors<\/strong><\/p>\n\n\n\n

Vivian Cervantes<\/p>\n\n\n\n

Gilmartin Group<\/p>\n\n\n\n

IR@bvimedical.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

WALTHAM, MA – May 1, 2023 (GLOBE NEWSWIRE) \u2014 BVI, a diversified global ophthalmic device company, today announced it has completed enrollment of its U.S. Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, FINEVISION\u00ae HP.  The milestone marks the final implantation of the 539th patient enrolled in the prospective, multicenter, […]<\/p>\n","protected":false},"author":9,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[17],"tags":[],"class_list":["post-5230","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/posts\/5230","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/comments?post=5230"}],"version-history":[{"count":0,"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/posts\/5230\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/media?parent=5230"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/categories?post=5230"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bvimedical.com\/us\/wp-json\/wp\/v2\/tags?post=5230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}