Implantable cardioverter defibrillators (ICDs) can save heart patients’ lives, but certain patients — older people, or those with co-morbidities such as heart failure or renal disease — are less likely to benefit from them than others, according to a new Canadian study.

In the study, lead researcher Douglas Lee, MD, PhD, from the Institute for Clinical Evaluative Sciences (Toronto), and colleagues gathered data on deaths among 2,467 people who received ICDs in Ontario.

Among these patients, more than 46% had heart failure, and when these patients were elderly, they had a 72% increased risk of dying compared with younger patients who didn’t have heart failure, Lee’s team found. Moreover, those with more than one preexisting medical condition were almost three times more likely to die after receiving an ICD than less-sick patients.

The study was published in the June 12 edition of the Journal of American College of Cardiology.

“I think it’s a good paper,” Bruce Lindsay, MD, president of the Heart Rhythm Society (HRS; Washington), told Medical Device Daily. “It’s sort of a common sense kind of thing — meaning it’s the kind of thing we’ve been weighing for a long time.”

In the study, the authors noted that ICDs have been demonstrated to be highly effective for heart patients, but that “In response to the widening indications for ICDs, there have been calls for better stratification methods to identify risk groups that would most benefit, or that would be unlikely to benefit, from the device.”

According to the study authors, their finding suggest that greater attention to non-cardiac co-morbidities and heart failure status may assist in the decision to implant an ICD and may improve outcomes in ICD recipients. However, the authors also note that “further research is needed to better characterize HF and other co-morbidities as potential determinants of outcome.”

It is difficult to tell from the study, Lindsay noted, the reasons why the patients in the study received a defibrillator. Some of them, he said, may have had one put in for primary prevention.

Overall, Lindsay said, if you take patients who are older — much above the age of 70 or 75 — or who have other co-morbidities, especially heart failure and renal disease, they are going to be less likely to benefit from an ICD than a younger patient or someone without other co-morbidities.

Lindsay said he believes age shouldn’t be a cut-off as much as the co-morbidities of heart failure and renal disease for who should or should not be implanted with a defibrillator.

In response to requests from the Centers for Medicare and Medicaid Services , Linsday said the HRS has worked collaboratively with the American College of Cardiology (Washington) to create a registry of patients who receive defibrillators.

The organizations reported the release of the National ICD Registry, calling it the nation’s first comprehensive database of detailed information about patients receiving these devices, at the annual HRS meeting in Denver last month (Medical Device Daily, May 10, 2007). The registry, an initiative launched in 2004, includes data provided by 1,450 hospitals, related to nearly 3,900 physicians and for more than 100,000 patients in its first year.

Along with this new study, the registry is expected to help doctors make better decisions about who gets these costly devices.

“These are life-saving technologies but they are expensive and it only makes sense to try to improve our selection of patients who get these devices,” Lindsay said.

ICDs cost around $30,000 each, plus hospital and doctor costs, according to data from the Connecticut Hospital Association (Wallingford, Connecticut). In addition, follow-up care and replacement of ICD components can cost between $44,000 and $144,000 for each year of additional life.

But it takes the implantation of 12 defibrillators in as many patients to save one life, Lindsay said.

“We need to cut that number down,” Lindsay said. “So a lot of work has gone into that. I think it’s a papers like this, and the registry, that will help. It’s just one piece that inches the field forward.”

The results of the study do not necessarily mean that someone who has a co-morbidity shouldn’t get an ICD, he noted, but that “as a physician, you need to stand back and look at the likelihood [that the patient will benefit from the device].”

Hologic to acquire BioLucent’s MammoPad business for $70M

A Medical Device Daily

Hologic (Bedford, Massachusetts), a provider of imaging systems for women’s health, reported that it has agreed to acquire BioLucent (Aliso Viejo, California) and its MammoPad breast cushion business.

With deal close, BioLucent will spin-off its brachytherapy business into a newly created company which will remain an independent firm.

The price for the transaction will be $70 million, subject to reduction in certain circumstances, plus a two-year earn-out. The closing price will consist of $5 million in cash and an additional $65 million, payable, at the election of Hologic, in cash, shares of Hologic common stock or a combination of both. The earn-out, if earned, will be payable in two annual cash installments not to exceed $15 million in the aggregate based upon BioLucent achieving certain revenue targets.

The deal is expected to close by the end of the third calendar quarter, after completion of a California fairness hearing, and will be subject to customary closing conditions, including BioLucent stockholder approval.

“Expanding our market share in women’s health is a key element in the growth of our company,” said Jack Cumming, Hologic CEO and chairman. “We believe this acquisition provides us additional technical capabilities and customer relationships to further solidify our position of strength in the growing mammography market.”

Cianna Medical is the new name for the company that will make BioLucent’s SAVI breast-brachytherapy device.

The team that developed and commercialized SAVI will remain with Cianna. Steve Gex, BioLucent’s CEO, will continue as the CEO of Cianna.

Cox said, “We created Cianna as a separate company because we believe a small company is the best environment to nurture innovation, address customer needs and develop SAVI’s full potential. We believe the SAVI brachytherapy applicator is a superior device for delivering precisely targeted radiation to the breast after lumpectomy.”

SAVI is intended to offer women who have had lumpectomy surgery a five-day course of treatment instead of the standard six weeks of treatment with external radiation.

The multi-catheter, expandable SAVI device treats tissue surrounding the lumpectomy cavity from the inside out.

BioLucent is a privately held company that makes the MammoPad breast cushion, a radiolucent foam cushion that covers the cold, hard surfaces of all commercially available mammography equipment, with the goal of reducing the discomfort that keeps many women from getting regular mammograms.

The company reported revenues of about $17 million in calendar 2006, a 42% increase over its prior year.

Hologic’s core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI for orthopedic applications.

In other dealmaking news:

Ithaka Acquisition (Miami) stockholders have approved the merger with Alsius (Irvine, California), the maker of the CoolGard system to control patient temperatures in hospital critical care settings.

Alsius will merge with a wholly owned subsidiary of Ithaka and change its name to Alsius Medical, and Ithaka will change its name to Alsius. The merger deal was first disclosed back in October (Medical Device Daily, Oct. 5, 2006).

Holders of Alsius equity and unsecured debt will receive eight million shares of Ithaka common stock. Alsius holders will receive up to five million additional performance shares upon achievement of revenues of $14.8 million, $28 million, and $47 million for the years ending Dec. 31, 2007, 2008, and 2009. Another one million performance shares will be awarded to Alsius holders upon more than 20% over-achievement of the revenue milestones in 2007, 2008 and 2009. Alsius management will receive bonus payments of $3 million with merger close and will be entitled to receive up to $2 million upon achievement of the same revenue targets described above.

The Alsius holders will not be able to sell any of the Ithaka shares they receive in the merger until one year after consummation of the merger, with only 50% of such shares becoming saleable 12 months after the merger and 50% becoming saleable 18 months after the merger.

At closing, the shares, warrants and units of Ithaka will continue trading on the Over-The-Counter Bulletin Board under the symbols OTCBB: ITHKU.OB, ITHK.OB, ITHKW.OB. The company has applied for listing on the NASDAQ and hopes to be listed as soon as possible following the closing.

Ithaka stockholders also approved certain changes to the company’s certificate of incorporation relating to the transaction, including the name change and an increase in authorized capitalization.

• The Agency of Medical Innovations (AMI; Feldkirch, Austria), reported that it has sold the EasyTAC fixation instrument to an undisclosed device manufacturer.

AMI is the device developer and manufacturer. Medchannel is AMI’s exclusive U.S. distribution partner and secured the device’s U.S. regulatory approval.

The EasyTAC device uses resorbable fixation elements for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic procedures, such as hernia repair. There are about one million hernia repair procedures in the U.S. annually.

Medchannel received 510(k) approval and commercialized the EasyTAC system in July 2006.

• Liberator Medical Supply (Stuart, Florida) said it has executed a definitive merger agreement with Liberator Medical Holdings (formerly Cardiff Communications).

Liberator will become a wholly owned subsidiary of Liberator Medical Holdings and Liberator’s shareholders will become shareholders of Liberator Medical Holdings.

Liberator Medical Supply is a national direct-to-consumer provider of medical supplies to Medicare-eligible seniors. About 75% of its revenue comes from supplying products to meet the requirements of diabetes, urological, ostomy and mastectomy patients.