Boston Scientific (Natick, Massachusetts), which has suffered through problems with its NIR with SOX stent system for the better part of the past 18 months, has received FDA approval to market the NIR with SOX over-the-wire coronary stent system for the treatment of coronary artery disease.
The company said that its Scimed cardiology division will begin shipments of the system immediately. The NIR with SOX incorporates the SOX system technology, which features patented sleeves that provide a smooth interface between the stent system and arterial wall. Additionally, the SOX system deployment focuses on the center rather than on the edges of the stent.
The company voluntarily recalled the NIR ON Ranger with SOX coronary stent system in October 1998, due to reports of balloon leakage in a small number of units, and the company says the new design changes "have been rigorously tested and validated." The NIR stent was developed and is manufactured by Medinol (Tel Aviv, Israel), and Boston Scientific has an exclusive worldwide license to market it.
St. Jude updates pacemaker notification
St. Jude Medical (St. Paul, Minnesota) has updated an earlier communication to physicians concerning its Trilogy pacemakers, notifying them again concerning what it terms "a microprocessor anomaly" that could create a malfunction. The notification is voluntary and the company said there have been no reported patient injuries associated with this situation. St. Jude is recommending continuation of patient monitoring, especially for those patients it describes as "pacemaker dependent." The notification is not related to any of the company's Trilogy pacemakers shipped after early 1999 or other St. Jude pacemaker or ICD products.
The malfunction – called an inappropriate pacing mode change to single-chamber pacing – has been reported in only 20 of 144,000 devices, and St. Jude estimates that about 20 others might have this problem. "Overall, the demonstrated reliability of the Trilogy family is in excess of 99%, which exceeds its design specification and is comparable to published pacemaker industry data," the company said in a statement.
Daniel Starks, president and CEO of the St. Jude Medical Cardiac Rhythm Management division, said that the clinical risk caused by the anomaly "is higher in most instances than the risk of Trilogy device malfunction. Overall, the Trilogy system is performing better than its design specification." He went on to say that the notification was in the interests of total disclosure and patient safety.
ComView offers telemedicine network
ComView (Pleasanton, California), a developer and manufacturer of innovative products used for capturing, archiving and displaying cardiac images, has launched a telemedicine network, available at www.ComView.com. The TeleCardiology Service, provided free, is the first in a series of offerings that will be supported through the new ComView TeleMedicine Network, according to the company.
Joseph Storm, ComView CEO, said that the service operates "by freely distributing the point-of-care tools and services that will improve the ability of physicians to communicate with their patients and to better collaborate with other physicians in order to quickly and efficiently improve care quality at lower costs." ComView specializes in high-performance digital products to record, view, archive, network, and generate reports for workstations that support cath lab, angiography, ultrasound, and nuclear medicine imaging needs.
Medtronic expands in Europe
Medtronic (Minneapolis, Minnesota) is planning a $31 million investment to expand its European headquarters and production site at Tolochenaz, Switzerland. The expansion, planned to be completed by 2006, will create 200 new jobs and more than double production capacity.
The current headquarters were opened in 1997 after an investment of $37 million. There is an existing team of 340 employees at Tolochenaz.
In a separate announcement, the French government has withdrawn its reimbursement authorization for Medtronic's triple-chamber Insync 8040 pacemaker. The product has been delisted just six months after approval.
Similar products from Ela Medical (Le Plessis Robinson, France) and St. Jude Medical (St. Paul, Minnesota) are under evaluation or in trials.
Angeion adjourns shareholder meeting
Angeion (Minneapolis, Minnesota) adjourned its latest shareholder meeting, held in mid-February, without obtaining sufficient noteholder response for two previously announced transactions with ELA Medical, a wholly owned subsidiary of the French pharmaceutical company Sanofi-Synthelabo and Medtronic (also Minneapolis).
Angeion shareholders had approved the transactions by a two-thirds vote on Feb. 4, but the company had adjourned the shareholder meeting until Feb. 17 to give noteholders additional time to vote on the transactions.
"We decided to adjourn the meeting after we did not obtain sufficient noteholder response," said Richard Jahnke, Angeion president and CEO. He said the company's board of directors was considering its various options.
On a related matter, Angeion said that on Feb. 17, Hennepin County District Judge Marilyn Brown Rosenbaum issued an order granting Angeion's motion for summary judgment in connection with a lawsuit brought by U.S. Bank NA on behalf of holders of Angeion's 7 1/2% senior convertible notes due in 2003. The court dismissed all claims of the plaintiff, with prejudice, ruling that certain transactions by Angeion in 1999 did not constitute a sale of all or substantially all of the assets under the indenture covering the notes, and that, therefore, noteholders were not entitled to prepayment of their notes.
Founded in 1986, Angeion acquired Medical Graphics in December 1999. Medical Graphics makes noninvasive cardiorespiratory diagnostic systems and related software for the management and improvement of cardiorespiratory health.
Cornelius to retire from Guidant post
Guidant (Indianapolis, Indiana) said that James Cornelius, chairman of the board, and former vice president and chief financial officer of Eli Lilly and Co., will retire as an employee of Guidant effective Aug. 1. Cornelius has had 33 years of combined Lilly/Guidant service.
Cornelius will continue to serve as chairman in a non-management status. Elected as Guidant's first board chairman in 1994, Cornelius was instrumental in the company's formation as a public company and split-off from Lilly. Cornelius said, "My new role will allow me to be more actively involved in the Cornelius Family Foundation and direct two new international Guidant advisory boards, one for Europe and the other for Japan."
Ronald Dollens, president and CEO now is directly responsible for the corporate support functions of finance, legal, and corporate compliance, formerly under the direction of Cornelius. Guidant has formed an office of the president which includes Dollens, along with A. Jay Graf, president of the company's Cardiac Rhythm Management Group, who becomes a group chairman, as does Ginger Graham, president of the Vascular Intervention Group.
Abiomed (Danvers, Massachusetts) has filed an amended version of its Registration Statement on Form S-3 with the Securities and Exchange Commission for a proposed public offering of 1.6 million shares of common stock to be offered by the company. Abiomed and one shareholder together have also granted the underwriters a 30-day option to purchase up to 225,000 shares to cover over-allotments. The company said it will use the net proceeds to fund the initial clinical trials of its AbioCor Implantable Replacement Heart, continued research and development, expansion of manufacturing capabilities, international sales and marketing, and general corporate purposes.
COR Therapeutics (South San Francisco, California) plans to raise $150 million through a convertible subordinated notes offering. The notes, due in 2007, will be convertible into COR's common stock at a price to be determined. COR also may issue an additional $50 million of notes to cover overallotments. The company intends to use proceeds for costs associated with the marketing and selling of Integrilin injection, as well as research and development activities and general corporate purposes. Integrilin, a synthetic peptide derived from the venom of the Southeastern pygmy rattlesnake, won FDA approval as an anti-clotting agent in 1998 for acute coronary syndrome (unstable angina and non-Q-wave myocardial infarction). It also is indicated for the treatment of patients undergoing percutaneous coronary interventions. The peptide is in Phase II trials for heart attack patients. Phase III trials are expected to begin by the end of this year or early next year.
CardioTech International (Woburn, Massachusetts) reported that the recent price and volume increases in the company's common stock have resulted in the right to call for the exercise of a total of 1.87 million common stock purchase warrants, of which 1.33 million warrants are currently outstanding. Calling exercise of the warrants would provide the company with an additional $2.4 million in working capital. CardioTech International develops polyurethane devices to treat late-stage cardiovascular disease, including a family of small-bore vascular graft devices using Chronoflex polyurethane materials.
MicroMed (Houston, Texas) reported raising $17.6 million, $5.6 million of it in venture capital. Funds will be used for research, clinical trials, and commercialization of the DeBakey Ventricular Assist Device (VAD) that the company is developing. Named for its developer, renowned heart specialist Michael DeBakey, the DeBakey VAD is an implantable pump providing increased blood flow from the ventricle of the heart throughout the body for those hearts unable to maintain adequate blood flow. In 1989, DeBakey, Dr. George Noon and the National Aeronautics and Space Administration (NASA) began joint R&D of the DeBakey VAD, using NASA-developed technology. MicroMed Technology (Houston) was formed in 1995 to develop the DeBakey VAD for commercial use. MicroMed said it believes the use of VADs could increase the addressable market dramatically, to a projected range of $2 billion to $4 billion annually.
Novametrix Medical Systems (Wallingford, Connecticut) completed a $3 million private equity placement with GE Marquette Medical Systems (Waukesha, Wisconsin). Novametrix issued 250,000 units at $12 per unit, each unit consisting of two shares of common stock and a five-year warrant to purchase one share at $7.50 each. The transaction is part of an expanded business relationship between the two companies, which also are negotiating agreements covering a variety of technology developments. Novametrix's products include electronic medical instruments and sensors for cardiac output, oxygen, carbon dioxide, and respiratory measurements.
Possis Medical (Minneapolis, Minnesota), a developer of cardiovascular and vascular devices, has secured $14.1 million through a private placement of common stock and another $900,000 in warrants with a group of institutional investors. The Tall Wind Fund was the lead investor, with Gerard, Klauer, Mattison & Co. as placement agent. Financing will be used to grow the company's U.S. direct sales organization, expansion of manufacturing operations, and new product development activities.
Qmed (Laurence Harbor, New Jersey) said it has received a $2 million investment from Quest Diagnostics (Teterboro, New Jersey), a provider of clinical testing, information and services, through acquisition of 2% of Qmed's outstanding stock. Michael Cox, Qmed president and CEO, called the investment "a major vote of confidence in our disease management business, a business in the early stages of rapid growth. It also indicates that our emerging Internet strategy as a preventive care multiplier for physician/patient interaction can be an important component of the future of healthcare through linking disease states more extensively to their risk factors." Qmed's ohms|cad (Online Health Management System for Coronary Artery Disease) combines patient-specific prognosis and national standard therapeutic recommendations to primary care doctors, while incorporating process reports of expense and health outcomes for the managed care organization.
Thoratec Laboratories (Pleasanton, California) said it will make a public offering of 4.5 million shares of common stock, consisting of 3 million newly issued shares and 1.5 million secondary shares sold by an existing shareholder, Gambro. Thoratec makes devices used for circulatory support and vascular graft applications.