Whatever else can be said about Boston Scientific (Natick, Massachusetts), you can't say it doesn't listen to investors and analysts. In apparent response to criticisms that the company lacks an ongoing flow of new products, Boston Scientific over the past few months has been reloading its pipeline through the acquisition of new companies and with fairly specific technologies and products. In a flurry of purchases, the company acquired four companies and their systems in the area of interventional cardiology.
The buying spree was launched in mid-February with perhaps the company's most significant purchase, the acquisition of Interventional Technologies (IVT; San Diego, California) and its Cutting Balloon system, in a deal valued at $345 million. IVT focuses on balloon angioplasty systems, with its most promising product being the Cutting Balloon technology which creates arterial dilation via tiny scalpels. The device received FDA commercial clearance last year and thus far has been used in an estimated 125,000 procedures worldwide, according to IVT.
That deal was followed about a week later with Boston Scientific's announcement that it will acquire Embolic Protection (EPI; Campbell, California) for $75 million, plus future milestones. The purchase gives Boston Scientific a path for entering the growing embolic protection side of interventional cardiology via EPI's Filterwire device. The device is a guidewire-mounted system for capturing dislodged embolic material that might travel through the bloodstream to the heart or brain and cause heart attack or stroke. And the purchase appears to complement intellectual property that Boston Scientific acquired from Embol-X last year.
On these heels of these two purchases, the company then made smaller acquisitions in the sector of drug and stent combinations for interventional use. At the very end of February, it purchased Quanam Medical (Santa Clara, California), a private company that develops medical devices using polymer technology, with a focus on drug/stent and drug delivery systems for cardiovascular applications. Quanam claims leadership in the arena of drug delivery via stents, and the acquisition will boost the company's drug-delivery portfolio with an additional implant-based system complemented by a family of proprietary biomaterials. The first compound being evaluated by Quanam is a paclitaxel derivative, and it initiated pilot studies in 1998 and is currently in ongoing pivotal trials in Europe.
The next acquisition, in early March, was the purchase of Catheter Innovations (Salt Lake City, Utah), a private maker of catheter-based venous access products used to deliver chemotherapy drugs, antibiotics and nutritional support to critically ill patients, and owned by capital company CB (Berkman Capital) Funds (Portland, Oregon). Catheter Innovations' product line incorporates its Pressure-Activated Safety Valve (PASV) protection technology, which includes a three-position valve that acts as an automated clamp to open inward for the long-term infusion of intravenous fluids and outward for blood withdrawal. Boston Scientific said the addition of Catheter Innovations' technology complements its strength in the non-valved sector of the venous access market offered through its own Medi-tech division and will expand its technology portfolio in the venous access market, which it estimated at $500 million annually. Company president and CEO Jim Tobin said that deal offered "further evidence of our commitment to leadership in the broad field of interventional medicine," an assessment that could be applied to all four acquisitions. Terms of the last two deals were not disclosed.
In the midst of this buying binge, however, Boston Scientific has not yet been able to reel in the largest prize it really wants – Medinol, its Israeli partner supplying the bulk of its stents and stent materials. Despite continuing assurances by Tobin that negotiations remain ongoing and active, sources close to both companies are predicting no early consummation of that deal and some have suggested that the negotiations might just as likely end in breakup.
No. 1 in dilatation market, says Guidant
Guidant (Indianapolis, Indiana) last month reported clearances of new coronary catheters, and said that the approvals give it the No. 1 position in the coronary dilatation field, which it describes as a $260 million-a-year market.
The company said it has received FDA clearance and equivalent regulatory approvals in Europe and Japan for its Powersail and Highsail coronary dilatation catheters used in treating blocked coronary arteries. The approvals mean that Guidant offers "a complete family of dilatation catheters for a spectrum of clinical needs" in a worldwide market. The catheters complement the Crossail and Opensail coronary dilation catheters the received approval last June. Powersail is on a rapid-exchange platform, while Highsail is an over-the-wire device.
Guidant said that in the past year it has increased its sales in the U.S. coronary dilatation catheter market by 21%, pushing its share of that sector from 34% to a first-place 41% share. John Capek, PhD, president of Guidant's Vascular Intervention unit, said that the new approvals complete a "comprehensive portfolio [which] will allow us to further advance our leadership position."
The catheters are used to open blocked coronary vessels during percutaneous transluminal coronary angioplasty and are indicated for use in native coronary vessels and vein grafts. A key feature is Guidant's Plateau balloon technology for treating harder, stenotic lesions. Plateau maintains balloon size under high pressure and enables repeated refolding and dilation.
On the downside, Guidant last month reported that it was issuing a voluntary recall of its Ancure Endograft System, used as a less-invasive approach to treating threatened abdominal aortic aneurysms (AAA), with the recall to result in a charge of from $12 million to $15 million. Recall of the AAA repair graft was followed by a skid of more than 6% in the company's share price.
The recall action was launched, according to the company, after identifying what it called "certain deficiencies in the ... Ancure-related regulatory processes and communications with the FDA. These regulatory deficiencies were primarily related to the deployment system of the Ancure product."
Ron Dollens, Guidant president and CEO, said in a statement that the company had notified the FDA concerning the problem and had scheduled a meeting with the agency to discuss it. "This review is a top priority, and we will be doing everything we can to correct the deficiencies and their causes and to resume normal operations as soon as possible," Dollens said.
The company said that the problems are related to the system's deployment and there is no safety risk to patients implanted with the Ancure. "As a result, the company does not recommend that physicians take any actions with regard to implanted devices, other than to continue normal follow-up," according to the statement. Guidant said that it was recalling the product from hospitals and is working with the FDA to address "all identified deficiencies" so as to resume production and distribution.
The company reported that Ancure system sales constitute from 3% to 4% of its total earnings. In its statement, Guidant said that excluding the estimated $12 million to $15 million charge, the company "is still comfortable with first-quarter consensus earnings estimates."
Abiomed on timeline for first implant
Abiomed's (Danvers, Massachusetts) timetable for the first implant of its battery-powered artificial heart remains unchanged despite a sooner-than-expected approval by the FDA. The company still expects to implant the first device in a human patient before June 30, said company spokesman Ed Berger during a conference call with analysts and investors early last month, but no firm date has yet been set. Berger said efforts involving legal, regulatory, team preparation, site preparation, patient selection and logistics are under way in preparation for the first implant. "As far as I know, there have been no setbacks and I am not aware of any issues that would cause us to revise our previously stated time frame," he said.
It was announced in late January that the FDA had granted permission for Abiomed to implant the AbioCor replacement heart in five patients as part of clinical trials under an investigational device exemption. Hospitals chosen so far to participate in the trials are Brigham and Women's Hospital, teamed with Massachusetts General Hospital (both Boston, Massachusetts); MCP Hahnemann University Hospital (Philadelphia, Pennsylvania); Jewish Heart and Lung Hospital (Louisville, Kentucky); Texas Heart Institute (Houston, Texas) and UCLA Medical Center (Los Angeles, California). International trials are expected after the U.S. trials are under way.
Success of the initial five-patient trial, once initiated, will be based upon periodic review of the survival of the AbioCor patients and their quality of life as measured by a variety of instruments previously validated for end-stage heart failure. The FDA letter authorizing the trial had required Abiomed to respond to a number of questions within 45 days, but initiation of the trial was not contingent upon those responses.
Described as "fist-sized" and weighing two pounds, the AbioCor is considered to be self-contained. The device is powered by an internal battery that can be recharged or operated off an external battery pack. As the world's first implantable artificial heart, the Abiocor is intended as a destination therapy for end-stage heart failure patients who are at risk of imminent death, are not transplantable and cannot be helped by other available therapies.
Abiomed said that unlike other heart pumps now in use, the AbioCor will entirely replace the patient's heart, which will be removed. Other pumps now in use are heart-assist devices, which are meant to help an ailing heart recover, or keep a patient alive until a suitable living heart can be transplanted.
Meridian providing products for j-v
Meridian Medical Technologies (Columbia, Maryland) said last month that it will manufacture cardiology telemedicine products for a new joint venture of Philips Medical Systems and SHL Telemedicine Ltd. in Europe (Report from Europe, page 8). The new venture, to be known as Philips Heart Care Telemedicine Services, was announced by Philips and SHL in January. It has the goals of marketing cardiology telemedicine products and services in targeted markets in Europe, establishing medical call centers and providing remote cardiac monitoring equipment and services for patients with heart disease. Operations are expected to begin later this year.
The venture will expand on SHL's 13-year success in Israel, which uses Meridian-produced equipment to provide home monitoring services for more than 55,000 heart patients. The first telemedicine products that will be supplied by Meridian include the new CardioBeeper CB12/12 cardiac monitor, which allows heart patients to transmit a complete 12-lead electrocardiogram (ECG) from home or office to medical personnel via a telephone line; the Cardio Pocket, a single-lead ECG device in a wallet; the Telepress Blood Pressure Monitor; and the Teleweight, a weight-trend monitor. All products are manufactured at Meridian's facility in Belfast, Northern Ireland.
News of new grants
Eagle Vision Pharmaceutical (Chester Springs, Pennsylvania) reported receiving a Small Business Innovative Research (SBIR) Phase 2 grant from the National Heart, Lung and Blood Institute (Bethesda, Maryland), part of the National Institutes of Health, to support studies of EVP 1001-1, the first cardiac-specific agent for use with magnetic resonance imaging (MRI).
While MRI offers the potential to provide a complete evaluation of the heart including structure, function, perfusion and metabolism, cardiac MRI has been limited by the lack of an imaging agent that identifies regions of the heart at risk of ischemic damage. EVP 1001-1 provides a superior approach that simplifies the diagnostic pathway for evaluating heart disease and replaces multiple tests with a single, noninvasive, cost-effective procedure, according to Eagle Vision. EVP 1001-1-enhanced MRI distinguishes areas of the heart receiving inadequate blood supply by providing high resolution, 3-D images that define which of these areas are likely to benefit from treatment and which will not. To date, the company has received three SBIR grants totaling nearly $1 million. EVP 1001-1 will be the focus of a presentation at the annual meeting of the International Society for Magnetic Resonance in Medicine.
Companies ... in brief
Clinimetrics Research Associates (San Jose, California), a contract research organization, has opened an office in Sydney, Australia, to serve as the company's base of operations for the Pacific Rim ... Magna-Lab (Syosset, New York) said it has retained Covance Health Economics and Outcomes Services (Gaithersburg, Maryland) to provide economic marketing and reimbursement strategy development for its CardiacView transesophageal MRI probe.